Клинические исследования препаратов при ЦМВИ в мире

данные на 03 апреля 2011


RankStatusStudy
1RecruitingPrevention Strategies for Transfusion-transmitted CMV(TT-CMV Birth Cohort Study)
Conditions:Cytomegalovirus;   Low Birth Weight Infant
Intervention:
Sponsor:Emory University
Gender:Both
Group:Child
Phase:
Number Enrolled:1300
Funded By:Other
Study Type:Observational
Study Design:Observational Model: Cohort;   Time Perspective: Prospective
NCT ID:NCT00907686
Other IDs:14684,   1P01HL086773-01A1
First Received Date:May 21, 2009
Start Date:January 2010
Completion Date:July 2015
Last Updated Date:April 21, 2010
Last Verified Date:January 2010
Acronym:TT-CMV
Primary Completion Date:September 2014
Outcome Measures:Determine point estimates (and confidence intervals) for the incidence of TT-CMV in LBWI of CMV seronegative & seropositive mothers.;   Determine if the risk of TT-CMV in LBWIs of CMV positive mothers is higher compared to LBWIs of CMV negative mothers;   Detect CMV DNA and/or elevated residual WBC counts in blood components transfused to LBWIs and determine whether these results are related to episodes of breakthrough TT-CMV in this population
2RecruitingEvaluation of the Artus® CMV PCR Test
Condition:Cytomegalovirus
Intervention:
Sponsor:QIAGEN Gaithersburg, Inc
Gender:Both
Age Groups:Adult / Senior
Phase:
Number Enrolled:216
Funded By:Industry
Study Type:Observational
Study Design:Observational Model: Cohort;   Time Perspective: Prospective
NCT ID:NCT01034709
Other IDs:C09-CMV-001
First Received Date:December 15, 2009
Start Date:December 2009
Completion Date:May 2011
Last Updated Date:October 18, 2010
Last Verified Date:October 2010
Acronym:CMV
Primary Completion Date:February 2011
Outcome Measures:Medical Decision Point #1 - the decision point at which the initial response/non-response to antiviral therapy is assessed.;   Medical Decision Point #2 - the decision point at which termination of standard antiviral therapy is made.
3Not yet recruitingAutologous Cytomegalovirus (CMV) Specific CD8+ T Cells as Treatment for CMV Reactivation
Conditions:CMV Reactivation;   Allogeneic Stem Cell Transplantation;   Autologous CMV Specific CD8+ T Cells
Interventions:Procedure: Lymphopheresis;   Procedure: CMV specific lymphocyte infusion;   Procedure: Peripheral blood for CMV DNA PCR;   Procedure: Haematology/Blood chemistry
Sponsor:Imperial College London
Gender:Both
Age Groups:Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:25
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT01326273
Other IDs:JROHH0202
First Received Date:March 22, 2011
Start Date:June 2011
Completion Date:June 2014
Last Updated Date:March 29, 2011
Last Verified Date:March 2011
Acronym:
Primary Completion Date:June 2014
Outcome Measures:Response to adoptive transfer of autologous CMV-specific CD8+ T-cells;   The occurrence of subsequent CMV reactivations;   Rate of complete response;   Rate of early complete response;   Rate of subsequent CMV reactivation
4CompletedA Clinical Trial of an Alphavirus Replicon Vaccine for Cytomegalovirus (CMV)
Condition:Cytomegalovirus Infections
Interventions:Biological: AVX601;   Biological: Placebo
Sponsor:AlphaVax, Inc.
Gender:Both
Group:Adult
Phase:Phase I
Number Enrolled:40
Funded By:Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
NCT ID:NCT00439803
Other IDs:AVX601-001
First Received Date:February 23, 2007
Start Date:April 2007
Completion Date:July 2008
Last Updated Date:November 7, 2008
Last Verified Date:November 2008
Acronym:CMV
Primary Completion Date:July 2008
Outcome Measures:evaluate safety of AVX601 based on teh frequency of Grade 2,3,or 4 systemic reactogenicity events;   evaluate the immunogenicity of AVX601 in healthy volunteers after 3 doses of vaccine
5Unknown CMV pp65 Specific T Cell Adoptive Immunotherapy in Allogeneic Stem Cell Transplantation for Malignant Disease
Condition:Allogeneic Stem Cell Transplantation
Intervention:Biological: CMV pp65 Specific T Cells
Sponsors:Duke University;   National Institutes of Health (NIH);   National Cancer Institute (NCI)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:18
Funded By:Other / NIH
Study Type:Interventional
Study Design:Intervention Model: Single Group Assignment;   Masking: Open Label
NCT ID:NCT00611637
Other IDs:4138-07-10R5,   IND 11649
First Received Date:January 29, 2008
Start Date:August 2005
Completion Date:
Last Updated Date:February 8, 2008
Last Verified Date:January 2008
Acronym:CMV-BMT
Primary Completion Date:February 2010
Outcome Measures:Number of CMV pp65 specific CD8+ T cells produced.;   Development of grade III-IV GVHD or major organ toxicity.;   Presence of CMV in peripheral blood.;   Percentage of CD8+ T cells that are CMV pp65 specific.
6RecruitingTrial of Donor T Cells Sensitized With Pentadecapeptides of the CMV-PP65 Protein for the Treatment of Cytomegalovirus (CMV) Infections Following Allogeneic Hematopoietic Stem Cell Transplants
Condition:Cytomegalovirus Infections
Intervention:Biological: CMV-Peptide-Specific T cells
Sponsor:Memorial Sloan-Kettering Cancer Center
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:30
Funded By:Other
Study Type:Interventional
Study Design:Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00674648
Other IDs:05-065
First Received Date:May 6, 2008
Start Date:August 2007
Completion Date:August 2011
Last Updated Date:November 2, 2010
Last Verified Date:November 2010
Acronym:
Primary Completion Date:August 2011
Outcome Measures:To assess the safety or toxicities of escalating doses of donor-derived CMV-pp65 peptide-specific T cells.;   To quantitate alterations in the level of CMV antigenemia in the blood of patients with either active infection or persistent antigenemia following adoptive transfer of CMV-pp65 peptide-specific T cells.
7CompletedCytomegalovirus (CMV) Specific Cytotoxic T Lymphocytes (CTL) When Used for Prophylaxis Against CMV in Recipients of Allogeneic, T Cell Depleted Stem Cell Transplants
Condition:Cytomegalovirus Infections
Intervention:Other: CMV Specific Cytotoxic T Lymphocytes
Sponsor:Penn State University
Gender:Both
Age Groups:Child / Adult
Phases:Phase I / Phase II
Number Enrolled:47
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00673868
Other IDs:26769
First Received Date:May 1, 2008
Start Date:October 2007
Completion Date:
Last Updated Date:January 22, 2009
Last Verified Date:April 2008
Acronym:
Primary Completion Date:
Outcome Measures:The primary objective is to characterize CMV specific immunity in subjects receiving and in those randomized to not receive CMV CTL. We will characterize CMV CTLp frequencies and bulk cytotoxicity at days 30 and 60 post infusion.;   To characterize the time to develop CMV specific immunity in pts. receiving and not receiving CTL by assessing CMV CTL;   To determine the CMV epitopes recognized by donors;   To characterize the levels of CMV DNA in recipients of CMV CTL and non CTL
8CompletedTrial of pDNA CMV Vaccine (VCL-CT02) Followed by Towne CMV Vaccine (Towne) Challenge
Condition:Cytomegalovirus Infection
Interventions:Biological: VCL CT02 pDNA vaccine;   Biological: Towne CMV vaccine
Sponsors:University of California, San Francisco;   Vical
Gender:Both
Group:Adult
Phase:Phase I
Number Enrolled:16
Funded By:Other / Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT00373412
Other IDs:Jacobson VCL CT-02 TC
First Received Date:September 6, 2006
Start Date:October 2006
Completion Date:
Last Updated Date:May 5, 2008
Last Verified Date:October 2006
Acronym:
Primary Completion Date:February 2008
Outcome Measures:CMV-specific immune response post-Towne challenge: gB antibody, T-cell IFN-g ELISPOT, T-cell proliferation assays for IE1, pp65, and/or gB, cytokine and phenotypic flow cytometry responses to pp65, IE1, gB.;   Safety of Towne challenge in subjects who have previously been immunized with a trivalent pDNA CMV vaccine (VCL-CT02).
9Active, not recruitingRecombinant CMV gB Vaccine in Postpartum Women
Condition:Cytomegalovirus Infections
Interventions:Biological: CMV gB vaccine;   Drug: MF59 adjuvant;   Drug: Placebo
Sponsors:University of Alabama at Birmingham;   National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Female
Age Groups:Child / Adult
Phase:Phase II
Number Enrolled:464
Funded By:Other / NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
NCT ID:NCT00125502
Other IDs:99-038,   U01-AI-063565,   sanofi pasteur CMC00
First Received Date:July 29, 2005
Start Date:August 1999
Completion Date:February 2010
Last Updated Date:May 11, 2009
Last Verified Date:May 2009
Acronym:
Primary Completion Date:June 2007
Outcome Measures:Time to CMV infection.;   Rate of CMV infection in CMV gB vaccine and placebo recipients.;   Rate of congenital CMV infection in offspring of the immunized women.;   Rate of local and systemic reactions and adverse events.;   Peak levels of antibody to CMV gB and neutralizing antibody and decline in antibody levels over time.;   Lymphocyte proliferation response to gB.
10RecruitingCertican® (Everolimus) Against Cytomegalovirus Disease in Renal Transplant Patients
Condition:Cytomegalovirus Infections
Interventions:Drug: Certican (everolimus) + valganciclovir;   Drug: Valganciclovir
Sponsor:Medical University of Vienna
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:40
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00828503
Other IDs:EudraCT: 2008-004745-28
First Received Date:January 23, 2009
Start Date:December 2008
Completion Date:June 2012
Last Updated Date:February 25, 2011
Last Verified Date:January 2009
Acronym:Certi-CMV
Primary Completion Date:December 2011
Outcome Measures:relative changes in CMV-load (copies/mL), as determined by qCMV-PCR from whole blood throughout the observational period;   CMV-load (copies/mL) after 1-8 weeks, in months 3, 4, 6 and 12; Time (in weeks) until the CMV-load reaches ≤600 copies/mL
11TerminatedCMV Infection in Adolescent Males
Condition:Cytomegalovirus Infections
Intervention:
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Male
Group:Child
Phase:
Number Enrolled:411
Funded By:NIH
Study Type:Observational
Study Design:Observational Model: Cohort;   Time Perspective: Prospective
NCT ID:NCT00302029
Other IDs:05-0126
First Received Date:March 9, 2006
Start Date:June 2006
Completion Date:December 2008
Last Updated Date:March 24, 2011
Last Verified Date:November 2009
Acronym:
Primary Completion Date:December 2008
Outcome Measures:Seroprevalence of CMV infection in adolescent boys;   Prospectively determine the incidence of CMV infection.;   Determine the duration and magnitude of CMV replication in the blood, urine, and saliva by specimens.;   Prospectively identify risk factors for infection.;   Identify risk factors for CMV infection by comparing those subjects who are CMV seropositive with those subjects who are CMV seronegative.
12RecruitingCytomegalovirus - Immunoprophylactic Adoptive Cellular Therapy Study
Condition:Cytomegalovirus Infection
Interventions:Biological: Adoptive Cellular Therapy;   Drug: Best available antiviral drug therapy
Sponsors:Cell Medica Ltd;   Wellcome Trust;   Choice Pharma Ltd;   Commitum AB;   BioAnaLab
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:110
Funded By:Industry / Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT01077908
Other IDs:CM-2008-01,   08/H0720/15,   74928896
First Received Date:February 26, 2010
Start Date:July 2008
Completion Date:
Last Updated Date:October 13, 2010
Last Verified Date:October 2010
Acronym:CMV-IMPACT
Primary Completion Date:July 2012
Outcome Measure:CMV reactivations
13CompletedPhase 1 Trial of CMV Towne Vaccine in Subjects Previously Received VCL CT02 Vaccine ID or IM
Condition:Cytomegalovirus Infection
Intervention:Biological: Towne CMV vaccine
Sponsors:University of California, San Francisco;   Vical
Gender:Both
Group:Adult
Phase:Phase I
Number Enrolled:10
Funded By:Other / Industry
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT00370006
Other IDs:Jacobson VCL CT-02 IDTC
First Received Date:August 28, 2006
Start Date:September 2006
Completion Date:August 2007
Last Updated Date:January 10, 2007
Last Verified Date:October 2006
Acronym:
Primary Completion Date:
Outcome Measures:CMV-specific immune response post-Towne challenge: gB antibody, T-cell IFN-g ELISPOT, T-cell proliferation assays for IE1, pp65, and/or gB, cytokine and phenotypic flow cytometry responses to pp65, IE1, gB.;   Safety of Towne challenge in subjects who have previously been immunized with a trivalent pDNA CMV vaccine (VCL-CT02).
14CompletedStudy to Evaluate Safety and Immunogenicity of the GSK Bio CMV Vaccine in CMV-Seronegative Healthy Male Adult Subjects
Condition:Cytomegalovirus
Intervention:Biological: GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A
Sponsor:GlaxoSmithKline
Gender:Male
Group:Adult
Phase:Phase I
Number Enrolled:40
Funded By:Industry
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT00435396
Other IDs:108890,   109211
First Received Date:February 14, 2007
Start Date:February 2007
Completion Date:
Last Updated Date:October 27, 2008
Last Verified Date:October 2008
Acronym:
Primary Completion Date:August 2008
Outcome Measures:Occurrence, intensity and relationship to vaccination of solicited local and general AEs.;   Occurrence, intensity and relationship to vaccination of unsolicited AEs.;   Occurrence and relationship to vaccination of any SAEs.;   Haematological and biochemical parameters.;   Anti-gB antibody avidity in all groups;;   Neutralizing anti-cytomegalovirus (CMV) antibody response in all groups;   Anti-CMV tegument proteins antibody response in all groups;;   Frequencies of CD4/CD8 T-cells with antigen-specific IFN-g, IL-2, TNF-a and/or CD40L secretion/expression to gB as determined by ICS in all groups;;   Anti-Herpes simplex virus (HSV) gD antibody response in all groups.;   Anti-glycoprotein B (gB) antibody concentrations in all groups;;   Anti-CMV Western Blot in all groups.
15RecruitingAlternate Donor Study of Pre-Emptive Cellular Therapy
Condition:Cytomegalovirus Infection
Intervention:Biological: CMV-specific T-cells, single infusion following single positive CMV PCR result
Sponsors:Cell Medica Ltd;   Leukaemia Lymphoma Research;   National Health Service, Blood and Transplant;   University of Birmingham
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase II
Number Enrolled:36
Funded By:Industry / Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT01220895
Other IDs:CM-2009-01
First Received Date:October 13, 2010
Start Date:October 2010
Completion Date:
Last Updated Date:February 16, 2011
Last Verified Date:February 2011
Acronym:CMV-ACE/ASPECT
Primary Completion Date:June 2012
Outcome Measure:Cytomegalovirus (CMV) specific immune reconstitution
16RecruitingEvaluation of Recovery From Drug-Induced Lymphopenia Using Cytomegalovirus-specific T-cell Adoptive Transfer
Conditions:Glioblastoma;   Cytomegalovirus
Interventions:Biological: CMV-ALT + CMV-DCs;   Biological: CMV-ALT + Saline
Sponsor:Duke University
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:12
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
NCT ID:NCT00693095
Other IDs:PRO00000580,   SPORE Project 3
First Received Date:June 3, 2008
Start Date:September 2008
Completion Date:December 2016
Last Updated Date:March 29, 2011
Last Verified Date:March 2011
Acronym:ERaDICATe
Primary Completion Date:June 2016
Outcome Measures:To evaluate if vaccinating adult patients with newly-diagnosed GBMs using CMV-DCs during recovery from therapeutic TMZ-induced lymphopenia with ALT in patients that are seropositive for CMV enhances the T-cell response.;   To evaluate the safety of ALT with CMV pp65-activated T-cells in adult patients with newly-diagnosed GBMs during recovery from therapeutic TMZ-induced lymphopenia.
17RecruitingAdministration of CMV-Specific Cytotoxic T Cells in Patients With Glioblastoma Multiforme
Conditions:Glioblastoma Multiforme;   Brain Cancer
Intervention:Biological: CMV-specific CTL
Sponsors:Baylor College of Medicine;   Texas Children's Hospital;   Center for Cell and Gene Therapy, Baylor College of Medicine;   The Methodist Hospital System
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:18
Funded By:Other
Study Type:Interventional
Study Design:Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT01205334
Other IDs:26901-COGLI
First Received Date:September 17, 2010
Start Date:November 2010
Completion Date:November 2020
Last Updated Date:March 4, 2011
Last Verified Date:March 2011
Acronym:COGLI
Primary Completion Date:November 2020
Outcome Measures:Primary: To evaluate the safety and persistence of escalating doses of autologous CMV-specific cytotoxic T-lymphocytes (CTL) in patients with CMV-positive Glioblastoma multiforme (GBM);   Secondary Objectives: To evaluate the effects of CMV-specific CTL on measurable disease.;   To measure the survival and function of CMV-specific CTL in vivo.
18Unknown Adoptive Immunotherapy for CMV Disease
Condition:CMV Disease
Intervention:Biological: CMV vaccine
Sponsor:Hadassah Medical Organization
Gender:Both
Age Groups:Child / Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:20
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00159055
Other IDs:280303-HMO-CTIL
First Received Date:September 9, 2005
Start Date:February 2004
Completion Date:
Last Updated Date:December 12, 2005
Last Verified Date:September 2005
Acronym:
Primary Completion Date:
Outcome Measures:Induce and amplify T cell-mediated immunotherapy against cytomegalovirus (CMV) infection in stem cell allograft recipients.;   Evaluate toxicity of the procedure.
19Not yet recruitingClinical Evaluation of Ultrashort-term Heat Inactivation of Cytomegalovirus (CMV) Containing Raw Breast Milk to Prevent CMV-infection of Preterm Infants
Conditions:Cytomegalovirus Infection;   Preterm Infants
Intervention:Procedure: ultrashort heat inactivation
Sponsor:University Hospital Tuebingen
Gender:Both
Group:Child
Phase:
Number Enrolled:
Funded By:Other
Study Type:Interventional
Study Design:Intervention Model: Single Group Assignment;   Primary Purpose: Prevention
NCT ID:NCT01178905
Other IDs:BM CMV inactivation
First Received Date:July 26, 2010
Start Date:August 2010
Completion Date:
Last Updated Date:August 9, 2010
Last Verified Date:July 2010
Acronym:
Primary Completion Date:August 2012
Outcome Measures:Number of participants with CMV viruria;   Number of participants with specific neonatal outcome parameters as a measure of neonatal quality
20TerminatedA Study Using Allogenic-Cytomegalovirus (CMV) Specific Cells for Glioblastoma Multiforme (GBM)
Condition:Glioblastoma Multiforme
Interventions:Drug: Fludarabine;   Drug: Cyclophosphamide;   Biological: CMV Specific Cytotoxic T Lymphocytes (CTL)
Sponsor:Penn State University
Gender:Both
Age Groups:Child / Adult
Phases:Phase I / Phase II
Number Enrolled:10
Funded By:Other
Study Type:Interventional
Study Design:Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00990496
Other IDs:31717,   PSHCI #09-045
First Received Date:October 5, 2009
Start Date:September 2009
Completion Date:September 2011
Last Updated Date:October 19, 2010
Last Verified Date:August 2010
Acronym:
Primary Completion Date:September 2011
Outcome Measures:To determine the incidence of tumor responses, as defined as stable disease, partial, or complete responses after the infusion of CMV CTL.;   To determine the duration and magnitude of donor chimerism post infusion by micro chimerism assays.;   To determine the incidence of increases in CMV pp65 or IE-1 T cells post infusion of allogeneic CMV CTL of GBM patients.;   To determine safety of allogeneic CTL infusions in this patient population.

RankStatusStudy
21RecruitingQuantiferon - Cytomegalovirus (CMV) and the Prediction of CMV Infection In High Risk Solid Organ Transplant Recipients
Condition:Cytomegalovirus Infection
Intervention:
Sponsor:University of Alberta
Gender:Both
Age Groups:Adult / Senior
Phase:
Number Enrolled:120
Funded By:Other
Study Type:Observational
Study Design:Observational Model: Cohort;   Time Perspective: Prospective
NCT ID:NCT00817908
Other IDs:7267
First Received Date:October 15, 2008
Start Date:May 2008
Completion Date:June 2012
Last Updated Date:February 25, 2011
Last Verified Date:February 2011
Acronym:
Primary Completion Date:December 2011
Outcome Measure:
22Not yet recruitingTrial of CMV Specific DLIs From 3-6/6 HLA Matched Family Member Following Nonmyeloablative Allo SCT
Condition:Cytomegalovirus Infections
Intervention:Biological: CMV Specific T Cell donor lymphocyte infusion
Sponsor:Duke University
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:32
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT01274377
Other IDs:00013947
First Received Date:January 9, 2011
Start Date:February 2011
Completion Date:February 2018
Last Updated Date:January 20, 2011
Last Verified Date:January 2011
Acronym:
Primary Completion Date:February 2016
Outcome Measures:Safety of CMV Specific T cell infusion following Stem Cell Transplant;   Efficacy of CMV-specific T cell infusion in terms of response, progression free survival, and overall survival;   Evaluate the recovery of immune function post engraftment with this regimen.
23RecruitingSafety, Toxicity and MTD of One Intravenous IV Injection of Donor CTLs Specific for CMV and Adenovirus
Conditions:Cytomegalovirus Infection;   Adenovirus Infection
Intervention:Biological: Dose Escalation Comparison
Sponsors:Baylor College of Medicine;   Texas Children's Hospital;   The Methodist Hospital System;   Center for Cell and Gene Therapy, Baylor College of Medicine
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:18
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00880789
Other IDs:23668-ACT CAT
First Received Date:April 13, 2009
Start Date:May 2009
Completion Date:May 2015
Last Updated Date:March 4, 2011
Last Verified Date:March 2011
Acronym:ACT-CAT
Primary Completion Date:May 2014
Outcome Measures:To determine safety, toxicity and MTD of one intravenous injection of donor-derived cytotoxic T lymphocytes (CTLs) specific for CMV and Adenovirus given to patients with or at risk for CMV and adenovirus disease after cord blood transplant;   To evaluate the feasibility of generating a sufficient number of umbilical cord blood-derived cytotoxic T lymphocytes (CTLs) specific for CMV and Adenovirus;   To evaluate the impact of these CTLs on Adenovirus-specific T-lymphocyte immune reconstitution.;   To evaluate the recovery of virus-specific immunity after CTL infusion and its correlation with viral clearance and/or protection from viral infection/disease.
24Unknown The Impact of Cytogam® on Time to Viral Load Reduction in Kidney or Kidney/Pancreas Transplant Recipients With Clinical CMV Disease
Condition:Cytomegalovirus
Intervention:Drug: CMV Immune globulin
Sponsor:University of Wisconsin, Madison
Gender:Both
Age Groups:Adult / Senior
Phase:
Number Enrolled:30
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00214240
Other IDs:1999-492
First Received Date:September 13, 2005
Start Date:January 2000
Completion Date:January 2008
Last Updated Date:December 17, 2007
Last Verified Date:December 2007
Acronym:
Primary Completion Date:
Outcome Measure:CMV viral load
25CompletedAccelerated Immunization to Induce Cytomegalovirus Immunity in Stem Cell Donors
Condition:Cytomegalovirus Infections
Intervention:Drug: ALVAC-CMV (vCP260)
Sponsor:National Heart, Lung, and Blood Institute (NHLBI)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:38
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT00353977
Other IDs:040198,   04-H-0198
First Received Date:July 18, 2006
Start Date:May 2004
Completion Date:March 2008
Last Updated Date:April 2, 2010
Last Verified Date:December 2009
Acronym:
Primary Completion Date:March 2008
Outcome Measures:Evaluate the efficacy of an accelerated ALVAC-pp65 immunization schedule in generating CMV-specific immunity in seronegative transplant donors and healthy volunteers (HV) and augmenting CMV-specific immunity in seropositive transplant donors and...;   To evaluate the clinical safety profile of the ALVAC-pp65 (vCP260) vaccine when given to CMV seronegative and seropositive individuals (donors or healthy volunteers).
26RecruitingInfection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
Conditions:Hematopoietic/Lymphoid Cancer;   Accelerated Phase Chronic Myelogenous Leukemia;   Acute Undifferentiated Leukemia;   Adult Acute Lymphoblastic Leukemia in Remission;   Adult Acute Myeloid Leukemia in Remission;   Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;   Adult Acute Myeloid Leukemia With Del(5q);   Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);   Adult Acute Myeloid Leukemia With T(15;17)(q22;q12);   Adult Acute Myeloid Leukemia With T(16;16)(p13;q22);   Adult Acute Myeloid Leukemia With T(8;21)(q22;q22);   Adult Grade III Lymphomatoid Granulomatosis;   Adult Nasal Type Extranodal NK/T-cell Lymphoma;   Anaplastic Large Cell Lymphoma;   Angioimmunoblastic T-cell Lymphoma;   Aplastic Anemia;   Atypical Chronic Myeloid Leukemia, BCR-ABL Negative;   Blastic Phase Chronic Myelogenous Leukemia;   Chronic Eosinophilic Leukemia;   Chronic Myelomonocytic Leukemia;   Chronic Neutrophilic Leukemia;   Chronic Phase Chronic Myelogenous Leukemia;   Contiguous Stage II Adult Burkitt Lymphoma;   Contiguous Stage II Adult Diffuse Large Cell Lymphoma;   Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma;   Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma;   Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma;   Contiguous Stage II Adult Lymphoblastic Lymphoma;   Contiguous Stage II Grade 1 Follicular Lymphoma;   Contiguous Stage II Grade 2 Follicular Lymphoma;   Contiguous Stage II Grade 3 Follicular Lymphoma;   Contiguous Stage II Mantle Cell Lymphoma;   Contiguous Stage II Marginal Zone Lymphoma;   Contiguous Stage II Small Lymphocytic Lymphoma;   Cutaneous B-cell Non-Hodgkin Lymphoma;   Cytomegalovirus Infection;   De Novo Myelodysplastic Syndromes;   Essential Thrombocythemia;   Extramedullary Plasmacytoma;   Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;   Intraocular Lymphoma;   Isolated Plasmacytoma of Bone;   Mast Cell Leukemia;   Meningeal Chronic Myelogenous Leukemia;   Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;   Nodal Marginal Zone B-cell Lymphoma;   Noncontiguous Stage II Adult Burkitt Lymphoma;   Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma;   Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma;   Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma;   Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma;   Noncontiguous Stage II Adult Lymphoblastic Lymphoma;   Noncontiguous Stage II Grade 1 Follicular Lymphoma;   Noncontiguous Stage II Grade 2 Follicular Lymphoma;   Noncontiguous Stage II Grade 3 Follicular Lymphoma;   Noncontiguous Stage II Mantle Cell Lymphoma;   Noncontiguous Stage II Marginal Zone Lymphoma;   Noncontiguous Stage II Small Lymphocytic Lymphoma;   Polycythemia Vera;   Post-transplant Lymphoproliferative Disorder;   Previously Treated Myelodysplastic Syndromes;   Primary Myelofibrosis;   Primary Systemic Amyloidosis;   Progressive Hairy Cell Leukemia, Initial Treatment;   Prolymphocytic Leukemia;   Recurrent Adult Acute Lymphoblastic Leukemia;   Recurrent Adult Acute Myeloid Leukemia;   Recurrent Adult Burkitt Lymphoma;   Recurrent Adult Diffuse Large Cell Lymphoma;   Recurrent Adult Diffuse Mixed Cell Lymphoma;   Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;   Recurrent Adult Grade III Lymphomatoid Granulomatosis;   Recurrent Adult Hodgkin Lymphoma;   Recurrent Adult Immunoblastic Large Cell Lymphoma;   Recurrent Adult Lymphoblastic Lymphoma;   Recurrent Adult T-cell Leukemia/Lymphoma;   Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;   Recurrent Grade 1 Follicular Lymphoma;   Recurrent Grade 2 Follicular Lymphoma;   Recurrent Grade 3 Follicular Lymphoma;   Recurrent Mantle Cell Lymphoma;   Recurrent Marginal Zone Lymphoma;   Recurrent Mycosis Fungoides/Sezary Syndrome;   Recurrent Small Lymphocytic Lymphoma;   Refractory Chronic Lymphocytic Leukemia;   Refractory Hairy Cell Leukemia;   Refractory Multiple Myeloma;   Relapsing Chronic Myelogenous Leukemia;   Secondary Acute Myeloid Leukemia;   Secondary Myelodysplastic Syndromes;   Secondary Myelofibrosis;   Splenic Marginal Zone Lymphoma;   Stage 0 Chronic Lymphocytic Leukemia;   Stage I Adult Burkitt Lymphoma;   Stage I Adult Diffuse Large Cell Lymphoma;   Stage I Adult Diffuse Mixed Cell Lymphoma;   Stage I Adult Diffuse Small Cleaved Cell Lymphoma;   Stage I Adult Hodgkin Lymphoma;   Stage I Adult Immunoblastic Large Cell Lymphoma;   Stage I Adult Lymphoblastic Lymphoma;   Stage I Adult T-cell Leukemia/Lymphoma;   Stage I Chronic Lymphocytic Leukemia;   Stage I Cutaneous T-cell Non-Hodgkin Lymphoma;   Stage I Grade 1 Follicular Lymphoma;   Stage I Grade 2 Follicular Lymphoma;   Stage I Grade 3 Follicular Lymphoma;   Stage I Mantle Cell Lymphoma;   Stage I Marginal Zone Lymphoma;   Stage I Multiple Myeloma;   Stage I Mycosis Fungoides/Sezary Syndrome;   Stage I Small Lymphocytic Lymphoma;   Stage II Adult Hodgkin Lymphoma;   Stage II Adult T-cell Leukemia/Lymphoma;   Stage II Chronic Lymphocytic Leukemia;   Stage II Cutaneous T-cell Non-Hodgkin Lymphoma;   Stage II Multiple Myeloma;   Stage II Mycosis Fungoides/Sezary Syndrome;   Stage III Adult Burkitt Lymphoma;   Stage III Adult Diffuse Large Cell Lymphoma;   Stage III Adult Diffuse Mixed Cell Lymphoma;   Stage III Adult Diffuse Small Cleaved Cell Lymphoma;   Stage III Adult Hodgkin Lymphoma;   Stage III Adult Immunoblastic Large Cell Lymphoma;   Stage III Adult Lymphoblastic Lymphoma;   Stage III Adult T-cell Leukemia/Lymphoma;   Stage III Chronic Lymphocytic Leukemia;   Stage III Cutaneous T-cell Non-Hodgkin Lymphoma;   Stage III Grade 1 Follicular Lymphoma;   Stage III Grade 2 Follicular Lymphoma;   Stage III Grade 3 Follicular Lymphoma;   Stage III Mantle Cell Lymphoma;   Stage III Marginal Zone Lymphoma;   Stage III Multiple Myeloma;   Stage III Mycosis Fungoides/Sezary Syndrome;   Stage III Small Lymphocytic Lymphoma;   Stage IV Adult Burkitt Lymphoma;   Stage IV Adult Diffuse Large Cell Lymphoma;   Stage IV Adult Diffuse Mixed Cell Lymphoma;   Stage IV Adult Diffuse Small Cleaved Cell Lymphoma;   Stage IV Adult Hodgkin Lymphoma;   Stage IV Adult Immunoblastic Large Cell Lymphoma;   Stage IV Adult Lymphoblastic Lymphoma;   Stage IV Adult T-cell Leukemia/Lymphoma;   Stage IV Chronic Lymphocytic Leukemia;   Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma;   Stage IV Grade 1 Follicular Lymphoma;   Stage IV Grade 2 Follicular Lymphoma;   Stage IV Grade 3 Follicular Lymphoma;   Stage IV Mantle Cell Lymphoma;   Stage IV Marginal Zone Lymphoma;   Stage IV Mycosis Fungoides/Sezary Syndrome;   Stage IV Small Lymphocytic Lymphoma;   T-cell Large Granular Lymphocyte Leukemia;   Waldenstrom Macroglobulinemia
Interventions:Procedure: infection prophylaxis and management;   Other: laboratory biomarker analysis;   Other: flow cytometry;   Genetic: DNA analysis;   Genetic: RNA analysis;   Procedure: management of therapy complications;   Drug: ganciclovir;   Drug: valganciclovir;   Drug: foscarnet sodium;   Procedure: antiviral therapy;   Genetic: polymerase chain reaction;   Genetic: protein expression analysis
Sponsors:City of Hope Medical Center;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Adult / Senior
Phase:
Number Enrolled:300
Funded By:Other / NIH
Study Type:Interventional
Study Design:Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
NCT ID:NCT01199562
Other IDs:09038,   NCI-2010-01932
First Received Date:September 8, 2010
Start Date:December 2010
Completion Date:
Last Updated Date:January 5, 2011
Last Verified Date:January 2011
Acronym:
Primary Completion Date:September 2014
Outcome Measures:Gancyclovir initiation;   NK (natural killer) immunity in CMV (cytomegalovirus) negative vs CMV positive;   Diagnosis of CMV pneumonia;   CMV disease, morbidity, and mortality;   Efficacy of an individualized strategy for CMV preemptive management on incidence of CMV disease, specifically CMV pneumonia;   CMV reaction-free survival;   Percent cytotoxicity and ex vivo percent CD56+/CD107B+ cells
27CompletedLong Term Use of Valganciclovir for Prophylaxis of CMV Disease in Kidney and Pancreas Transplant Patients
Conditions:CMV Disease;   Viral Resistance;   Rejection;   Death
Intervention:
Sponsors:University of Massachusetts, Worcester;   Beth Israel Deaconess Medical Center;   Lahey Clinic;   Rhode Island Hospital
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:100
Funded By:Other
Study Type:Observational
Study Design:Observational Model: Defined Population;   Observational Model: Natural History;   Time Perspective: Longitudinal;   Time Perspective: Prospective
NCT ID:NCT00225394
Other IDs:VAL031
First Received Date:September 21, 2005
Start Date:October 2003
Completion Date:July 2006
Last Updated Date:September 21, 2005
Last Verified Date:August 2005
Acronym:
Primary Completion Date:
Outcome Measure:
28RecruitingDose-escalation Study of the Safety, Tolerability and Ability of CMX001 to Prevent or Control Cytomegalovirus (CMV) Infection in R+ Hematopoietic Stem Cell Transplant Recipients
Condition:Cytomegalovirus Infection
Interventions:Drug: CMX001;   Drug: Placebo
Sponsor:Chimerix
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:150
Funded By:Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
NCT ID:NCT00942305
Other IDs:CMX001-201
First Received Date:July 17, 2009
Start Date:October 2009
Completion Date:
Last Updated Date:March 18, 2011
Last Verified Date:March 2011
Acronym:
Primary Completion Date:October 2011
Outcome Measures:Safety endpoints include clinical assessments and laboratory values, incidence adn severity of GvHD, AEs (and SAEs). Efficacy endpoint includes lack of emergence or progression of CMV infection.;   Emergence or increase in CMV DNA, Occurrence of CMV diseasePatient drop-out and/or discontinuation rate,Trough levels of CMX001, CDV, and other metabolites,urine and/or plasma levels of AdV, BKV, or EBV DNA
29Active, not recruitinggB/MF59 Vaccine in Preventing Cytomegalovirus Infection in Healthy Adolescent Females
Condition:Cytomegalovirus Infections
Interventions:Biological: MF-59;   Drug: Placebo;   Biological: CMV gB vaccine
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Female
Group:Child
Phase:Phase II
Number Enrolled:409
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
NCT ID:NCT00133497
Other IDs:04-039
First Received Date:August 19, 2005
Start Date:June 2006
Completion Date:April 2013
Last Updated Date:March 24, 2011
Last Verified Date:March 2010
Acronym:
Primary Completion Date:March 2013
Outcome Measures:Efficacy: systemic cytomegalovirus (CMV) infection, defined by the detection of CMV in the urine or blood, which will be evaluated by CMV detection by polymerase chain reaction (PCR).;   Safety: incidence of local and systemic reactions, as determined by self-reported assessments using a memory aid, adverse events (AEs) and serious adverse events (SAEs).;   Duration and magnitude of CMV replication in the urine and blood as determined from specimens.;   Immunologic: CMV antibody measurements by CMV neutralization, enzyme-linked immunosorbent assay (ELISA), and CMV glycoprotein B (gB) assay.;   Efficacy: CMV infections defined as seroconversion to nonvaccine CMV antigens or identification of CMV in the blood or urine.
30RecruitingProspective Multicentric Study of Cytomegalovirus Resistance in Transplant Patients and Bone Marrow Recipients
Condition:Cytomegalovirus
Intervention:Biological: depistage
Sponsor:University Hospital, Limoges
Gender:Both
Age Groups:Child / Adult / Senior
Phase:
Number Enrolled:800
Funded By:Other
Study Type:Interventional
Study Design:Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT01008540
Other IDs:I06016
First Received Date:November 5, 2009
Start Date:August 2006
Completion Date:June 2011
Last Updated Date:November 5, 2009
Last Verified Date:November 2009
Acronym:PHRC CMV
Primary Completion Date:December 2009
Outcome Measures:Resistance incidence in our patients with subgroup analysis, by organ and by the use of prophylaxis or preemptive treatment;   Strain diversity in baseline isolates and in resistant isolates Frequency of known resistance mutations Identification of new resistance-related mutations.
31CompletedCytomegalovirus (CMV) Vaccine in Donors and Recipients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)
Conditions:Acute Lymphoblastic Leukemia;   Chronic Myelogenous Leukemia;   Acute Myelogenous Leukemia;   Hodgkin's Lymphoma;   Non-Hodgkin's Lymphoma;   Myelodysplastic Syndrome
Interventions:Biological: VCL-CB01;   Other: PBS
Sponsor:Vical
Gender:Both
Group:Adult
Phase:Phase II
Number Enrolled:240
Funded By:Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
NCT ID:NCT00285259
Other IDs:CB01-202
First Received Date:January 30, 2006
Start Date:January 2006
Completion Date:November 2010
Last Updated Date:December 15, 2010
Last Verified Date:July 2010
Acronym:
Primary Completion Date:November 2009
Outcome Measures:Safety of CMV immunotherapeutic vaccine in donors and recipients undergoing HCT;   occurrence rate of clinically significant CMV viremia in recipients receiving CMV immunotherapeutic vaccine.
32Unknown Influence of Persistent CMV-Infection on Immune Senescence
Condition:Immune Senescence
Intervention:Biological: Vaccination against TBEV (FSME Immun CC)
Sponsors:University of Zurich;   Division of Infectious Diseases and Hospital Epidemiology
Gender:Both
Group:Senior
Phase:Phase IV
Number Enrolled:120
Funded By:Other
Study Type:Interventional
Study Design:Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
NCT ID:NCT00461695
Other IDs:CYTEL-Protocol V1.A1
First Received Date:April 17, 2007
Start Date:May 2007
Completion Date:December 2008
Last Updated Date:June 5, 2008
Last Verified Date:June 2008
Acronym:
Primary Completion Date:August 2008
Outcome Measures:Geometric mean titer (GMT) of anti-TBEV-antibodies measured by TBEV-neutralisation assay and ELISA one month after each TBEV-vaccine administration in the group of CMV-seropositive versus CMV-seronegative individuals;   Efficacy of TBEV-vaccination in healthy elderly individuals (Geometric mean antibody titer measured by TBEV-neutralisation test).;   Safety of TBEV-vaccination in healthy elderly individuals.
33RecruitingStudy of Administration of CMV-specific Cytotoxic T Lymphocytes Expressing CAR Targeting HER2 in Patients With GBM
Condition:Brain Cancer
Intervention:Drug: HER.CAR CMV-specific CTL
Sponsors:Baylor College of Medicine;   The Methodist Hospital System;   Center for Cell and Gene Therapy, Baylor College of Medicine;   Texas Children's Hospital
Gender:Both
Age Groups:Child / Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:18
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT01109095
Other IDs:H-24487 - HERT GBM
First Received Date:April 13, 2010
Start Date:October 2010
Completion Date:October 2031
Last Updated Date:March 4, 2011
Last Verified Date:March 2011
Acronym:HERT-GBM
Primary Completion Date:October 2016
Outcome Measures:Evaluating the safety and persistence of escalating doses CTL;   Evaluating and Measuring the effects of gene modified CTL
34CompletedCell Mediated Immunity and the Prediction of CMV Infection In Solid Organ Transplant Recipients
Condition:Transplant
Intervention:Procedure: Monitoring-blood samples drawn for CMV testing
Sponsors:University Health Network, Toronto;   The Physicians' Services Incorporated Foundation
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:150
Funded By:Other
Study Type:Observational
Study Design:
NCT ID:NCT00436384
Other IDs:05-0265-AE
First Received Date:February 15, 2007
Start Date:November 2005
Completion Date:March 2008
Last Updated Date:April 15, 2008
Last Verified Date:February 2007
Acronym:
Primary Completion Date:March 2008
Outcome Measure:
35SuspendedEvaluation of the Immunogenicity and Efficacy of the Towne Strain of CMV in Seronegative Women
Condition:Cytomegalovirus Infections
Interventions:Biological: Hepatitis A Vaccine;   Biological: Towne CMV Vaccine
Sponsors:Virginia Commonwealth University;   National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Female
Group:Adult
Phases:Phase II / Phase III
Number Enrolled:180
Funded By:Other / NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Prevention
NCT ID:NCT00201448
Other IDs:94-078
First Received Date:September 13, 2005
Start Date:
Completion Date:
Last Updated Date:April 21, 2009
Last Verified Date:September 2005
Acronym:
Primary Completion Date:
Outcome Measure:
36Unknown Comparison of Oral Valganciclovir and Placebo for the Prevention of Cytomegalovirus (CMV) After Lung Transplantation
Condition:Cytomegalovirus Infections
Intervention:Drug: valganciclovir
Sponsors:Duke University;   Hoffmann-La Roche
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:130
Funded By:Other / Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
NCT ID:NCT00227370
Other IDs:Val038
First Received Date:September 26, 2005
Start Date:July 2003
Completion Date:January 2008
Last Updated Date:January 2, 2008
Last Verified Date:January 2008
Acronym:Valgan
Primary Completion Date:April 2008
Outcome Measures:For Enrollment Phase , using descriptive statistics, the safety and efficacy of an open label regimen that includes initial intravenous ganciclovir followed by oral valganciclovir for 3 months post transplant for patients at risk for CMV;   For Randomization Phase , determine the rate of CMV disease at one year in the short course as compared to extended prophylaxis groups in Phase II;   Determine whether prevention of CMV disease after transplantation improves clinical outcomes. The researchers will compare the rates of acute rejection, hospitalization, non-CMV infections, and survival between the 2 groups over the study period.;   Determine how treatment with valganciclovir affects quality of life (QOL) by comparing serial measures of QOL between groups;   Determine how one year of oral valganciclovir affects ganciclovir resistance by comparing the rate of resistance between the groups
37Active, not recruitingA Study of Valcyte (Valganciclovir) CMV Prophylaxis After Renal Transplantation
Condition:Cytomegalovirus Infections
Interventions:Drug: valganciclovir [Valcyte];   Drug: Pre-emptive therapy
Sponsor:Hoffmann-La Roche
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:301
Funded By:Industry
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT00372229
Other IDs:ML19313
First Received Date:September 5, 2006
Start Date:May 2006
Completion Date:December 2015
Last Updated Date:September 30, 2010
Last Verified Date:September 2010
Acronym:
Primary Completion Date:
Outcome Measures:Percentage of patients with active CMV infection, or CMV disease.;   Urine proteomic pattern;   Time to graft loss;   CMV syndrome or tissue invasive disease; viremia; acute rejection; creatinine clearance; leucopenia and neutropenia; opportunistic infections; graft and patient survival.
38CompletedCMV Disease and IRIS in HIV-1 Infected Persons
Conditions:HIV Infections;   Cytomegalovirus
Intervention:Genetic: IE gene
Sponsor:Kaohsiung Medical University Chung-Ho Memorial Hospital
Gender:Both
Age Groups:Child / Adult / Senior
Phase:
Number Enrolled:200
Funded By:Other
Study Type:Observational
Study Design:
NCT ID:NCT00456664
Other IDs:QM094007
First Received Date:April 4, 2007
Start Date:November 2006
Completion Date:July 2008
Last Updated Date:February 1, 2009
Last Verified Date:May 2008
Acronym:
Primary Completion Date:July 2008
Outcome Measure:
39CompletedProphylaxis With Ganciclovir Improves Graft Survival in Renal Allograft Recipients
Conditions:DNA Virus Infection;   Herpesviridae Infections;   Cytomegalovirus Infection
Intervention:Drug: Ganciclovir
Sponsor:Lower Saxony Center for Nephrology
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:150
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT00373165
Other IDs:ML19827
First Received Date:September 5, 2006
Start Date:August 2000
Completion Date:October 2003
Last Updated Date:September 12, 2006
Last Verified Date:September 2006
Acronym:
Primary Completion Date:
Outcome Measure:The impact of CMV infection on graft function, incidence of CMV infection and creatinine clearance in both study groups at month 12. long-term graft and patient survival. Neutrophil counts and creatinine clearance were measured on a regular basis.
40No longer availableEmergency Use of Adoptive Immunotherapy With CMV-Specific T Cells After Donor Bone Marrow Transplant of an Infant With Immunodeficiency Syndrome and CMV Infection
Conditions:Infection;   Precancerous/Nonmalignant Condition
Interventions:Biological: therapeutic allogeneic lymphocytes;   Procedure: allogeneic bone marrow transplantation;   Radiation: total-body irradiation
Sponsors:Fred Hutchinson Cancer Research Center;   National Cancer Institute (NCI)
Gender:Female
Group:Child
Phase:
Number Enrolled:
Funded By:Other / NIH
Study Type:Expanded Access
Study Design:
NCT ID:NCT00547235
Other IDs:2215.00,   FHCRC-2215.00,   CDR0000570998
First Received Date:October 19, 2007
Start Date:September 2007
Completion Date:
Last Updated Date:August 23, 2010
Last Verified Date:August 2010
Acronym:
Primary Completion Date:December 2012
Outcome Measure:

RankStatusStudy
41CompletedVICTOR Study - A Study of Valcyte (Valganciclovir po) Compared to Ganciclovir iv in Patients With Cytomegalovirus (CMV) Disease Who Are Solid Organ Transplant Recipients
Condition:Cytomegalovirus Infections
Interventions:Drug: valganciclovir [Valcyte];   Drug: Ganciclovir
Sponsor:Hoffmann-La Roche
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:325
Funded By:Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00431353
Other IDs:MV17973
First Received Date:February 2, 2007
Start Date:
Completion Date:August 2008
Last Updated Date:May 13, 2009
Last Verified Date:May 2009
Acronym:
Primary Completion Date:
Outcome Measures:Incidence of treatment success (CMV viremia BLQ);   Time to eradication of CMV viremia, percentage of patients with resolution of symptoms, percentage of patients with eradication of CMV viremia, time to CMV viremia recurrence, effect on HHV-6, HHV-7 and EBV viremia.;   AEs, laboratory parameters, appearance of ganciclovir resistance.
42Completed
Has Results
IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients
Condition:Cytomegalovirus Infections
Intervention:Drug: Valganciclovir
Sponsor:Hoffmann-La Roche
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:326
Funded By:Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
NCT ID:NCT00294515
Other IDs:NT18435
First Received Date:February 21, 2006
Start Date:March 2006
Completion Date:August 2009
Last Updated Date:July 30, 2010
Last Verified Date:July 2010
Acronym:IMPACT
Primary Completion Date:August 2008
Outcome Measures:Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant;   Percentage of Patients Who Developed CMV Disease up to Month 6 Post-transplant;   Percentage of Patients Who Developed CMV Disease up to Month 9 Post-transplant;   Percentage of Patients Who Developed CMV Disease up to Month 18 Post-transplant;   Percentage of Patients Who Developed CMV Disease up to Month 24 Post-transplant
43CompletedPhase I/II Study of Human Anti-Cytomegalovirus (CMV) Monoclonal Antibody MSL-109 in Newborns With Symptomatic Congenital CMV Infection Without Central Nervous System Disease
Condition:Cytomegalovirus Infections
Intervention:Drug: SDZ MSL-109
Sponsors:National Center for Research Resources (NCRR);   National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Group:Child
Phases:Phase I / Phase II
Number Enrolled:
Funded By:NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00004642
Other IDs:199/11673,   NIAID-3748
First Received Date:February 24, 2000
Start Date:February 1995
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:March 1999
Acronym:
Primary Completion Date:
Outcome Measure:
44RecruitingCytomegalovirus (CMV) MicroRNA Expression in Vivo and Immune Evasion Correlates
Condition:Transplant
Intervention:
Sponsor:University of Alberta
Gender:Both
Age Groups:Adult / Senior
Phase:
Number Enrolled:30
Funded By:Other
Study Type:Observational
Study Design:Observational Model: Cohort;   Time Perspective: Prospective
NCT ID:NCT00677482
Other IDs:7304
First Received Date:May 12, 2008
Start Date:April 2008
Completion Date:June 2011
Last Updated Date:December 21, 2010
Last Verified Date:December 2010
Acronym:
Primary Completion Date:June 2011
Outcome Measure:
45Active, not recruitingValganciclovir in Prevention of Cytomegalovirus (CMV) Reactivation Following Allogeneic-Stem Cell Transplantation (SCT)
Conditions:Bone Marrow Transplantation;   Cytomegalovirus
Interventions:Drug: Valganciclovir;   Drug: Acyclovir
Sponsor:Hadassah Medical Organization
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:40
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT00330018
Other IDs:MYS-03-HMO-CTIL
First Received Date:May 24, 2006
Start Date:February 2006
Completion Date:April 2010
Last Updated Date:September 16, 2010
Last Verified Date:August 2009
Acronym:
Primary Completion Date:April 2010
Outcome Measures:Prevention of CMV reactivation;   Occurrence of CMV disease;   Overall survival;   Occurrence of GVHD;   Occurrence of other infections
46RecruitingStudy of the Transmission of Cytomegalovirus (CMV) Infection From Mother to Foetus
Conditions:Infections, Cytomegalovirus;   Transmission of Cytomegalovirus Infection From Pregnant Woman to Foetus
Interventions:Procedure: Blood sample;   Procedure: Cord blood sample;   Procedure: Saliva swab;   Procedure: Urine sampling;   Procedure: Vaginal swab
Sponsor:GlaxoSmithKline
Gender:Female
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:90
Funded By:Industry
Study Type:Interventional
Study Design:Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
NCT ID:NCT01251744
Other IDs:113134
First Received Date:November 30, 2010
Start Date:December 2010
Completion Date:March 2015
Last Updated Date:January 28, 2011
Last Verified Date:December 2010
Acronym:
Primary Completion Date:March 2015
Outcome Measures:Occurrence of congenital CMV infection in newborns or foetuses of subjects who had a confirmed primary CMV infection during pregnancy.;   Evidence of CMV in saliva, urine, blood or vaginal secretions of pregnant subjects with a confirmed primary CMV infection at protocol-defined timepoints.;   Assessment of antibody responses to CMV of pregnant subjects with a confirmed primary CMV infection at protocol-defined timepoints.;   Assessment of the cell-mediated immune responses of pregnant subjects with a confirmed primary CMV infection at protocol-defined timepoints.
47SuspendedCytomegalovirus (CMV) Transmission by Frozen Breast Milk in Preterms
Condition:Cytomegalovirus
Intervention:
Sponsor:Johann Wolfgang Goethe University Hospitals
Gender:Both
Group:Child
Phase:
Number Enrolled:58
Funded By:Other
Study Type:Observational
Study Design:Time Perspective: Prospective
NCT ID:NCT00668798
Other IDs:CMV/MM0105/FFM
First Received Date:April 25, 2008
Start Date:January 2005
Completion Date:March 2008
Last Updated Date:April 28, 2008
Last Verified Date:April 2008
Acronym:
Primary Completion Date:January 2008
Outcome Measures:CMV status of preterm infants;   clinical manifestations of CMV infection
48Active, not recruitingMaribavir Versus Oral Ganciclovir For The Prevention of Cytomegalovirus (CMV) Disease in Liver Transplant Recipients
Condition:Cytomegalovirus Infections
Interventions:Drug: maribavir;   Drug: ganciclovir
Sponsor:ViroPharma
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:348
Funded By:Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
NCT ID:NCT00497796
Other IDs:1263-301
First Received Date:July 5, 2007
Start Date:July 2007
Completion Date:
Last Updated Date:August 11, 2009
Last Verified Date:August 2009
Acronym:
Primary Completion Date:
Outcome Measures:CMV disease;   Incidence of CMV infection;   Incidence of graft rejection;   Incidence of retransplantation;   Mortality
49Unknown Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus (CMV) Disease in Stem Cell Transplant Recipients
Condition:Cytomegalovirus Infections
Interventions:Drug: maribavir;   Other: placebo
Sponsor:ViroPharma
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:613
Funded By:Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
NCT ID:NCT00411645
Other IDs:1263-300
First Received Date:December 12, 2006
Start Date:December 2006
Completion Date:May 2009
Last Updated Date:August 25, 2010
Last Verified Date:June 2008
Acronym:
Primary Completion Date:November 2008
Outcome Measures:CMV organ disease;   Incidence of CMV infection;   Incidence of graft-versus-host disease;   Mortality
50RecruitingCytotoxic T-Lymphocytes for the Prophylaxis of Cytomegalovirus After Allogeneic Stem Cell Transplant
Conditions:Stem Cell Transplantation;   Cytomegalovirus Infections
Intervention:Biological: CMV CTL infusion
Sponsors:Baylor College of Medicine;   The Methodist Hospital System;   Texas Children's Hospital;   Center for Cell and Gene Therapy, Baylor College of Medicine
Gender:Both
Age Groups:Child / Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:40
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00078533
Other IDs:12683-VICTA,   VICTA
First Received Date:March 1, 2004
Start Date:April 2004
Completion Date:December 2021
Last Updated Date:March 4, 2011
Last Verified Date:March 2011
Acronym:VICTA
Primary Completion Date:December 2021
Outcome Measures:safety, toxicity and maximum tolerated dose (MTD);   Efficacy of recovery of virus-specific immunity and correlation with protection from viral reactivation/disease.
51CompletedCytomegalovirus Hyperimmune Globulin (CMV-Ig) Replacement in Hypogammaglobulinemic Lung Transplant Recipients
Condition:Hypogammaglobulinemia
Intervention:Drug: CMV-Ig
Sponsor:The Cleveland Clinic
Gender:Both
Age Groups:Child / Adult / Senior
Phases:Phase II / Phase III
Number Enrolled:50
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT00137748
Other IDs:IRB2953
First Received Date:August 29, 2005
Start Date:January 2001
Completion Date:January 2006
Last Updated Date:June 8, 2010
Last Verified Date:June 2010
Acronym:
Primary Completion Date:January 2006
Outcome Measure:CMV infection
52CompletedEfficacy of Elevated CD4 Counts on CMV Retinitis
Conditions:Acquired Immunodeficiency Syndrome;   Cytomegalovirus Retinitis
Intervention:
Sponsor:National Eye Institute (NEI)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:
Number Enrolled:15
Funded By:NIH
Study Type:Observational
Study Design:
NCT ID:NCT00091884
Other IDs:040223,   04-EI-0223
First Received Date:September 17, 2004
Start Date:July 2004
Completion Date:April 2005
Last Updated Date:March 3, 2008
Last Verified Date:April 2005
Acronym:
Primary Completion Date:
Outcome Measure:
53CompletedA Study of HIV and Cytomegalovirus (CMV) in HIV-Infected Patients
Conditions:Cytomegalovirus Infections;   HIV Infections
Intervention:
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:
Number Enrolled:400
Funded By:NIH
Study Type:Observational
Study Design:Observational Model: Natural History
NCT ID:NCT00001089
Other IDs:ACTG 360
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:February 2003
Acronym:
Primary Completion Date:
Outcome Measure:
54RecruitingInjection of CD4 and CD8 + T Cells Anti-Cytomegalovirus (CMV) or Anti-adenovirus
Conditions:Cytomegalovirus Infections;   Adenovirus Infections
Intervention:Other: Cell therapy
Sponsor:Assistance Publique - Hôpitaux de Paris
Gender:Both
Age Groups:Child / Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:30
Funded By:Other
Study Type:Interventional
Study Design:Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT01325636
Other IDs:P090801
First Received Date:March 28, 2011
Start Date:March 2010
Completion Date:September 2012
Last Updated Date:March 29, 2011
Last Verified Date:March 2011
Acronym:CTLantiCMV
Primary Completion Date:September 2012
Outcome Measures:CMV blood viral load by PCR;   GvHa evaluation;   Evaluation of clinical signs according to interested organs (lung, liver, bowel,…);   Increase of T cells
55CompletedPreventing Cytomegalovirus (CMV) Organ Damage With Valganciclovir in People With HIV
Conditions:Cytomegalovirus Infections;   HIV Infections
Intervention:Drug: Valganciclovir
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:350
Funded By:NIH
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Masking: Double-Blind;   Primary Purpose: Prevention
NCT ID:NCT00006145
Other IDs:ACTG A5030,   AACTG A5030,   DAIDS-ES ID 10170
First Received Date:August 7, 2000
Start Date:
Completion Date:
Last Updated Date:February 23, 2011
Last Verified Date:August 2009
Acronym:
Primary Completion Date:February 2006
Outcome Measure:
56RecruitingT-Lymphocyte Infusion or Standard Therapy in Treating Patients at Risk of Cytomegalovirus Infection After a Donor Stem Cell Transplant
Condition:Cancer
Interventions:Biological: adoptive immunotherapy;   Biological: alemtuzumab;   Biological: in vitro-treated peripheral blood lymphocyte therapy;   Drug: foscarnet sodium;   Drug: ganciclovir;   Genetic: polymerase chain reaction;   Procedure: allogeneic hematopoietic stem cell transplantation;   Procedure: infection prophylaxis and management;   Procedure: peripheral blood stem cell transplantation;   Procedure: standard follow-up care;   Radiation: radiation therapy
Sponsor:University Hospital Birmingham
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase II
Number Enrolled:78
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Masking: Open Label;   Primary Purpose: Supportive Care
NCT ID:NCT00986557
Other IDs:CDR0000650654,   CRC-TU-ACE-CMV,   53325562,   EU-20974
First Received Date:September 29, 2009
Start Date:September 2009
Completion Date:
Last Updated Date:April 9, 2010
Last Verified Date:April 2010
Acronym:
Primary Completion Date:August 2013
Outcome Measures:CMV reactivation in the first year after ASCT measured by quantitative PCR;   CMV-specific T-cell reconstitution by detection of circulating T-cell responses to CMV in the first year after ASCT;   Time to CMV reactivation;   Use of antiviral therapy;   Incidence of secondary CMV reactivation and CMV disease;   Incidence of acute and chronic graft-versus-host disease
57CompletedThe Safety and Effectiveness of Different Dose Levels of 1263W94 in the Treatment of Cytomegalovirus (CMV) of the Eyes in HIV-Infected Patients
Conditions:Cytomegalovirus Infections;   HIV Infections
Intervention:Drug: Maribavir
Sponsor:Glaxo Wellcome
Gender:Male
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:56
Funded By:Industry
Study Type:Interventional
Study Design:Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
NCT ID:NCT00002373
Other IDs:263A,   CMAA1003
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:November 1998
Acronym:
Primary Completion Date:
Outcome Measure:
58CompletedImmune Response to Cytomegalovirus
Condition:Cytomegalovirus Infections
Intervention:
Sponsor:National Heart, Lung, and Blood Institute (NHLBI)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:
Number Enrolled:20
Funded By:NIH
Study Type:Observational
Study Design:
NCT ID:NCT00034437
Other IDs:020189,   02-H-0189
First Received Date:April 27, 2002
Start Date:April 2002
Completion Date:April 2003
Last Updated Date:March 3, 2008
Last Verified Date:April 2003
Acronym:
Primary Completion Date:
Outcome Measure:
59CompletedA Trial to Study How the Body Fights Off Cytomegalovirus (CMV) in Hematopoietic Transplant Recipients.
Condition:Cytomegalovirus Infection
Intervention:
Sponsor:Mayo Clinic
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:50
Funded By:Other
Study Type:Observational
Study Design:Observational Model: Defined Population;   Observational Model: Natural History;   Time Perspective: Longitudinal;   Time Perspective: Prospective
NCT ID:NCT00273143
Other IDs:1052-05
First Received Date:January 6, 2006
Start Date:May 2005
Completion Date:
Last Updated Date:January 6, 2006
Last Verified Date:January 2006
Acronym:
Primary Completion Date:
Outcome Measure:
60CompletedValganciclovir in Congenital CMV Infants
Condition:Cytomegalovirus Infections
Interventions:Drug: Valganciclovir;   Drug: Ganciclovir
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Group:Child
Phases:Phase I / Phase II
Number Enrolled:24
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00031434
Other IDs:01-595,   CASG 109
First Received Date:March 6, 2002
Start Date:July 2002
Completion Date:July 2007
Last Updated Date:February 3, 2011
Last Verified Date:July 2009
Acronym:
Primary Completion Date:July 2007
Outcome Measures:Pharmacokinetics of ganciclovir following administration of oral valganciclovir syrup. The pharmacokinetics will be assessed by a population approach to PK data analysis.;   Pharmacokinetics of valganciclovir following administration of oral valganciclovir syrup.;   Lack of vomiting and/or diarrhea associated with administration of oral valganciclovir syrup.;   Correlation of ganciclovir plasma concentrations following administration of intravenous ganciclovir and oral valganciclovir syrup with CMV whole blood viral load.;   Assessment of toxicity, such as neutropenia, associated with the administration of oral valganciclovir syrup.
RankStatusStudy
61RecruitingSafety Study of Four Chimera Cytomegalovirus (CMV) Vaccines in Healthy Adult Males 30-50 Years of Age
Condition:Cytomegalovirus
Intervention:Biological: cmv vaccine
Sponsors:Virginia Commonwealth University;   International AIDS Vaccine Initiative
Gender:Male
Group:Adult
Phase:Phase I
Number Enrolled:36
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT01195571
Other IDs:1
First Received Date:September 2, 2010
Start Date:September 2010
Completion Date:March 2012
Last Updated Date:November 10, 2010
Last Verified Date:September 2010
Acronym:
Primary Completion Date:March 2012
Outcome Measure:Safety
62CompletedMaribavir for Prevention of CMV After Stem Cell Transplants
Condition:Cytomegalovirus Infection
Intervention:Drug: maribavir
Sponsor:ViroPharma
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:108
Funded By:Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Prevention
NCT ID:NCT00223925
Other IDs:1263-200
First Received Date:September 13, 2005
Start Date:
Completion Date:
Last Updated Date:June 19, 2006
Last Verified Date:June 2006
Acronym:
Primary Completion Date:
Outcome Measures:Safety and tolerabilty for up to 12 weeks of dosing;   Incidence of CMV infection;   Incidence of CMV disease
63CompletedA Phase III Study to Evaluate the Safety and Efficacy of Ganciclovir (Dihydroxypropoxymethyl Guanine [DHPG]) Treatment of Symptomatic Central Nervous System (CNS) Congenital Cytomegalovirus (CMV) Infections.
Condition:Cytomegalovirus Infections
Intervention:Drug: ganciclovir
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Group:Child
Phase:Phase III
Number Enrolled:130
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00001100
Other IDs:DMID ARB-AL-91-CMV,   DAB-AL-558607
First Received Date:November 2, 1999
Start Date:
Completion Date:November 2005
Last Updated Date:August 26, 2010
Last Verified Date:November 2005
Acronym:
Primary Completion Date:
Outcome Measure:
64CompletedThe Study is Being Done to See if Taking the Drug Valganciclovir Can Prevent CMV Infection.
Condition:Bone Marrow Stem Cell Transplant
Intervention:Drug: Valganciclovir
Sponsors:Mayo Clinic;   Hoffmann-La Roche;   Fred Hutchinson Cancer Research Center;   City of Hope National Medical Center;   University of Florida;   University of Michigan
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:20
Funded By:Other / Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Prevention
NCT ID:NCT00275665
Other IDs:2124-01
First Received Date:January 10, 2006
Start Date:November 2001
Completion Date:July 2007
Last Updated Date:September 11, 2009
Last Verified Date:September 2009
Acronym:
Primary Completion Date:July 2007
Outcome Measures:CMV disease;   Invasive bacterial and fungal infections;   The occurrence of CMV infection or the occurrence of CMV disease (whichever occurs first) between enrollment and day 270 after transplantation.;   Occurrence of CMV disease between randomization and day 270;   The occurrence of other documented clinically significant human herpesvirus infections after randomization and day 270.;   Survival to include a comparison of treatments at day 270 and day 640;   Safety-comparison of adverse events and serious adverse events that occur on the two arms during the study
65CompletedNeonatal CMV-Ganciclovir Follow-up Study
Condition:Cytomegalovirus Infections
Intervention:
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Group:Child
Phase:
Number Enrolled:8
Funded By:NIH
Study Type:Observational
Study Design:
NCT ID:NCT00031421
Other IDs:01-489,   CASG 108
First Received Date:March 6, 2002
Start Date:September 2001
Completion Date:November 2005
Last Updated Date:August 26, 2010
Last Verified Date:July 2008
Acronym:
Primary Completion Date:
Outcome Measure:
66CompletedTAMOVALCIR in Allogenic Hematopoietic Progenitors Transplant
Condition:Cytomegalovirus Infection
Intervention:Drug: Valganciclovir
Sponsor:PETHEMA Foundation
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase II
Number Enrolled:132
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00386412
Other IDs:2005-002813-19.,   TAMOVALCIR in alogenic
First Received Date:October 9, 2006
Start Date:November 2005
Completion Date:September 2009
Last Updated Date:September 17, 2009
Last Verified Date:September 2009
Acronym:
Primary Completion Date:September 2009
Outcome Measures:To value valganciclovir efficacy in advance treatment of CMV in patients received allogenic transplant with a uniform treatment.;   To value valganciclovir security in advance treatment of CMV in in patients received allogenic transplant with a uniform treatment.
67Active, not recruitingCMV Glycoprotein B Vaccine in Allograft Recipients
Condition:Cytomegalovirus Infections
Interventions:Biological: CMV gB vaccine;   Drug: Placebo
Sponsors:University College, London;   National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:140
Funded By:Other / NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
NCT ID:NCT00299260
Other IDs:04-107,   R01AI051355
First Received Date:March 3, 2006
Start Date:August 2006
Completion Date:September 2011
Last Updated Date:April 16, 2010
Last Verified Date:January 2008
Acronym:
Primary Completion Date:September 2009
Outcome Measures:safety;   immunogenicity;   viral load;   correlate of immune protection
68CompletedFoscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Foscarnet sodium
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult
Phase:Phase I
Number Enrolled:53
Funded By:NIH
Study Type:Interventional
Study Design:Endpoint Classification: Pharmacokinetics Study;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00000726
Other IDs:ACTG 015,   FDA 20D
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:February 1992
Acronym:
Primary Completion Date:
Outcome Measure:
69TerminatedA Study of Cidofovir in HIV-Infected Children With Cytomegalovirus (CMV) Disease
Conditions:Cytomegalovirus Infections;   Cytomegalovirus Retinitis;   HIV Infections
Interventions:Drug: Cidofovir;   Drug: Probenecid
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Group:Child
Phase:Phase I
Number Enrolled:14
Funded By:NIH
Study Type:Interventional
Study Design:Endpoint Classification: Pharmacokinetics Study;   Primary Purpose: Treatment
NCT ID:NCT00000881
Other IDs:ACTG 352
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:September 1998
Acronym:
Primary Completion Date:
Outcome Measure:
70CompletedStudies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Trial: Foscarnet-Ganciclovir Component
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Interventions:Drug: Foscarnet sodium;   Drug: Ganciclovir
Sponsors:National Institute of Allergy and Infectious Diseases (NIAID);   Johns Hopkins University
Gender:Both
Age Groups:Child / Adult / Senior
Phase:
Number Enrolled:240
Funded By:NIH / Other
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00000665
Other IDs:ACTG 129,   FDA 46A,   FDA/00095
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:March 11, 2011
Last Verified Date:December 1994
Acronym:
Primary Completion Date:April 1992
Outcome Measure:
71CompletedThe Effects of Genetic Differences Among AIDS Patients on Cytomegalovirus Retinitis
Condition:CMV Disease
Intervention:
Sponsor:National Cancer Institute (NCI)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:
Number Enrolled:2000
Funded By:NIH
Study Type:Observational
Study Design:
NCT ID:NCT00341172
Other IDs:999905023,   05-C-N023
First Received Date:June 19, 2006
Start Date:October 2004
Completion Date:
Last Updated Date:February 18, 2011
Last Verified Date:November 2010
Acronym:
Primary Completion Date:
Outcome Measure:
72CompletedA Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Sevirumab
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase II
Number Enrolled:300
Funded By:NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00000836
Other IDs:ACTG 294
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:August 1998
Acronym:
Primary Completion Date:
Outcome Measure:
73CompletedA Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Ganciclovir
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:
Funded By:NIH
Study Type:Interventional
Study Design:Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00000698
Other IDs:TX 303
First Received Date:November 2, 1999
Start Date:
Completion Date:August 2007
Last Updated Date:September 26, 2008
Last Verified Date:April 1992
Acronym:
Primary Completion Date:
Outcome Measure:
74CompletedA Study to Evaluate the Effects of Stopping Maintenance Therapy for Cytomegalovirus (CMV) Retinitis After Effective Anti-HIV Therapy
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:
Number Enrolled:75
Funded By:NIH
Study Type:Observational
Study Design:
NCT ID:NCT00000905
Other IDs:ACTG 379
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:July 28, 2008
Last Verified Date:June 2003
Acronym:
Primary Completion Date:
Outcome Measure:
75CompletedA Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Ganciclovir
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult
Phase:Phase I
Number Enrolled:38
Funded By:NIH
Study Type:Interventional
Study Design:Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00000673
Other IDs:ACTG 085
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:July 31, 2008
Last Verified Date:October 1994
Acronym:
Primary Completion Date:
Outcome Measure:
76Unknown Genotyping of Cytomegalovirus From Patients in Israel
Condition:Cytomegalovirus Infections
Intervention:
Sponsor:Sheba Medical Center
Gender:Both
Age Groups:Child / Adult / Senior
Phase:
Number Enrolled:100
Funded By:Other
Study Type:Observational
Study Design:Additional Descriptors: Convenience Sample;   Observational Model: Natural History;   Time Perspective: Cross-Sectional;   Time Perspective: Retrospective
NCT ID:NCT00228202
Other IDs:SHEBA-05-3867-NK-CTIL,   Sara Orzi MSc thesis
First Received Date:September 26, 2005
Start Date:September 2005
Completion Date:
Last Updated Date:August 17, 2006
Last Verified Date:January 2006
Acronym:
Primary Completion Date:
Outcome Measure:
77TerminatedA Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS Who Cannot Use Ganciclovir
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Foscarnet sodium
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult
Phase:Phase II
Number Enrolled:168
Funded By:NIH
Study Type:Interventional
Study Design:Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
NCT ID:NCT00000697
Other IDs:ACTG 092
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:November 1989
Acronym:
Primary Completion Date:
Outcome Measure:
78CompletedA Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus
Conditions:Cytomegalovirus Infections;   HIV Infections
Intervention:Drug: Ganciclovir
Sponsor:Hoffmann-La Roche
Gender:Both
Age Groups:Child / Adult / Senior
Phase:
Number Enrolled:700
Funded By:Industry
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Masking: Double-Blind;   Primary Purpose: Treatment
NCT ID:NCT00002095
Other IDs:059D,   ICM 1654
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:November 1993
Acronym:
Primary Completion Date:
Outcome Measure:
79Unknown Valganciclovir in Patients With CMV Retinitis and AIDS Who Cannot Take Drugs by Injection
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Valganciclovir
Sponsor:Hoffmann-La Roche
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:500
Funded By:Industry
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Primary Purpose: Treatment
NCT ID:NCT00017784
Other IDs:268C,   ML16356
First Received Date:June 11, 2001
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:June 2001
Acronym:
Primary Completion Date:
Outcome Measure:
80TerminatedA Phase I/II Pilot Treatment Study Of CSF Penetration And Response To Ganciclovir And Foscarnet In CMV Neurologic Disease.
Conditions:Encephalopathy;   HIV Infections;   Radiculitis
Interventions:Drug: Foscarnet sodium;   Drug: Ganciclovir
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:30
Funded By:NIH
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
NCT ID:NCT00000856
Other IDs:ACTG 305
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:July 31, 2008
Last Verified Date:March 2004
Acronym:
Primary Completion Date:
Outcome Measure:
RankStatusStudy
81RecruitingSafety Study of Recombinant Adeno-Associated Virus Acid Alpha-Glucosidase to Treat Pompe Disease
Condition:Pompe Disease
Intervention:Drug: rAAV1-CMV-GAA
Sponsors:University of Florida;   National Heart, Lung, and Blood Institute (NHLBI)
Gender:Both
Group:Child
Phases:Phase I / Phase II
Number Enrolled:6
Funded By:Other / NIH
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00976352
Other IDs:PGTC PD-AAV004
First Received Date:July 13, 2009
Start Date:September 2010
Completion Date:January 2013
Last Updated Date:November 16, 2010
Last Verified Date:November 2010
Acronym:
Primary Completion Date:December 2012
Outcome Measures:Assessment of the safety of intramuscular administration of a recombinant adeno-associated virus, rAAV1-CMV-GAA, vector in children with ventilator-dependent Pompe disease.;   Impact of gene transfer to the diaphragm will be assessed by detailed pulmonary function studies
82CompletedMeasuring Changes in Blood in Patients at High Risk of Cytomegalovirus Infection After Undergoing Donor Bone Marrow Transplant or Peripheral Blood Stem Cell Transplant
Conditions:Chronic Myeloproliferative Disorders;   Leukemia;   Lymphoma;   Multiple Myeloma and Plasma Cell Neoplasm;   Myelodysplastic Syndromes;   Myelodysplastic-Myeloproliferative Diseases;   Nonneoplastic Condition
Interventions:Drug: ganciclovir;   Genetic: polymerase chain reaction;   Other: flow cytometry;   Other: immunologic technique;   Procedure: allogeneic bone marrow transplantation;   Procedure: allogeneic hematopoietic stem cell transplantation;   Procedure: assessment of therapy complications;   Procedure: peripheral blood stem cell transplantation
Sponsors:City of Hope Medical Center;   National Cancer Institute (NCI);   National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Adult / Senior
Phase:
Number Enrolled:100
Funded By:Other / NIH
Study Type:Interventional
Study Design:Primary Purpose: Supportive Care
NCT ID:NCT00716911
Other IDs:99061,   R01AI058148,   P30CA033572,   CHNMC-99061,   CDR0000600022
First Received Date:July 15, 2008
Start Date:January 2000
Completion Date:
Last Updated Date:March 4, 2011
Last Verified Date:March 2011
Acronym:
Primary Completion Date:July 2007
Outcome Measures:Quantitative determination of HLA-peptide tetramer-binding assay (TBA) pp65 on days 40 and 90 after stem cell transplantation, with and without in vitro stimulation;   Comparison of quantitative determination of TBApp65 with concomitant determination of in vitro CMV-specific cytotoxic T-lymphocyte function on days 40 and 90 after stem cell transplantation;   Correlation of TBApp65 results with CMV viral loads;   Correlation of TBApp65 results with CMV-associated complications;   Correlation of TBApp65 results with clinical events, including acute graft-versus-host-disease (GVHD), chronic GVHD, ganciclovir exposure, and survival
83Unknown Efficacy and Safety of Valcyte® as an Add-on Therapy in Patients With Malignant Glioblastoma and Cytomegalovirus (CMV) Infection
Conditions:Glioblastoma Multiforme;   Cytomegalovirus Infection
Intervention:Drug: Valganciclovir (Valcyte)
Sponsor:Karolinska University Hospital
Gender:Both
Age Groups:Adult / Senior
Phase:
Number Enrolled:40
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
NCT ID:NCT00400322
Other IDs:MV20145,   Eudra CT: 2006-002022-29
First Received Date:November 15, 2006
Start Date:August 2006
Completion Date:March 2009
Last Updated Date:January 21, 2009
Last Verified Date:January 2009
Acronym:
Primary Completion Date:
Outcome Measures:Tumor size;   Disease status;   Patient survival
84CompletedThe Safety and Effectiveness of Ganciclovir in the Prevention of Cytomegalovirus (CMV) of the Eyes and Disease of the Stomach and Intestines in Patients With HIV
Conditions:Cytomegalovirus Retinitis;   HIV Infections;   Gastrointestinal Diseases
Intervention:Drug: Ganciclovir
Sponsors:National Institute of Allergy and Infectious Diseases (NIAID);   Hoffmann-La Roche
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase II
Number Enrolled:850
Funded By:NIH / Industry
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
NCT ID:NCT00001034
Other IDs:CPCRA 023
First Received Date:November 2, 1999
Start Date:
Completion Date:August 2007
Last Updated Date:September 26, 2008
Last Verified Date:August 2004
Acronym:
Primary Completion Date:
Outcome Measure:
85CompletedComparison of Two Drugs, Cidofovir and Ganciclovir, in Treating Patients With AIDS Who Have CMV Retinitis
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Interventions:Drug: Cidofovir;   Drug: Probenecid;   Drug: Ganciclovir
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase IV
Number Enrolled:300
Funded By:NIH
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
NCT ID:NCT00000894
Other IDs:ACTG 350
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:February 22, 2011
Last Verified Date:June 2003
Acronym:
Primary Completion Date:June 2000
Outcome Measure:
86CompletedPotential Role of CMV in Restenosis Following Angioplasty, in Atherosclerosis, and in Endothelial Dysfunction
Conditions:Arterial Occlusive Diseases;   Atherosclerosis;   Coronary Disease;   Cytomegalovirus Infections
Intervention:
Sponsor:National Heart, Lung, and Blood Institute (NHLBI)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:
Number Enrolled:355
Funded By:NIH
Study Type:Observational
Study Design:
NCT ID:NCT00001531
Other IDs:960099,   96-H-0099
First Received Date:November 3, 1999
Start Date:June 1996
Completion Date:September 2000
Last Updated Date:March 3, 2008
Last Verified Date:August 1999
Acronym:
Primary Completion Date:
Outcome Measure:
87CompletedA Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Foscarnet sodium
Sponsor:Astra USA
Gender:Both
Group:Adult
Phase:
Number Enrolled:
Funded By:Industry
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00002432
Other IDs:020E,   89-FOS-06
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:July 1990
Acronym:
Primary Completion Date:
Outcome Measure:
88CompletedA Phase I/II Trial to Assess the Safety and Tolerance of Escalating Doses of a Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Retinitis
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Sevirumab
Sponsor:Sandoz Inc.
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:
Funded By:Industry
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00002016
Other IDs:071B,   Study No B103
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:April 1993
Acronym:
Primary Completion Date:
Outcome Measure:
89RecruitingMost Closely HLA Matched Allogeneic Virus Specific Cytotoxic T-Lymphocytes (CTL)
Conditions:Adenovirus Infection;   EBV Infection
Intervention:Biological: Most Closely Matched CTLs with Adenovirus
Sponsors:Baylor College of Medicine;   Texas Children's Hospital;   The Methodist Hospital System;   Brigham and Women's Hospital;   Massachusetts General Hospital;   M.D. Anderson Cancer Center;   National Marrow Donor Program;   The EMMES Corporation;   Duke University;   Beth Israel Deaconess Medical Center;   Children's Hospital Los Angeles;   National Heart, Lung, and Blood Institute (NHLBI);   Children's Hospital Boston;   University of Miami;   Hackensack University Medical Center
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:45
Funded By:Other / Industry / NIH
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00711035
Other IDs:22994-CHALLAH,   CHALLAH
First Received Date:June 20, 2008
Start Date:November 2008
Completion Date:July 2012
Last Updated Date:March 4, 2011
Last Verified Date:March 2011
Acronym:CHALLAH
Primary Completion Date:July 2010
Outcome Measure:The primary purpose of the study is to assess the safety of administering CHM-CTLs in transplant patients with EBV, CMV, or adenovirus infection. We have elected to use a dose of 2 x 107 CHM-CTLs/m2.
90RecruitingIn UTERO Treatment of Cytomegalovirus Congenital Infection With Valacyclovir
Conditions:Viral Disease;   Cytomegalovirus Infection
Interventions:Drug: Valacyclovir (ZELITREX);   Drug: Placebo
Sponsor:Assistance Publique - Hôpitaux de Paris
Gender:Female
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:164
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
NCT ID:NCT01037712
Other IDs:P070115
First Received Date:December 21, 2009
Start Date:September 2009
Completion Date:June 2013
Last Updated Date:February 23, 2011
Last Verified Date:February 2011
Acronym:CYMEVAL
Primary Completion Date:June 2013
Outcome Measures:pregnancies with unfavourable exit (symptomatic children at birth or medical interruptions of pregnancy practised for which has appeared cerebral echographic anomalies in connection with the fetal infection with CMV) at 24 hours;   the viral load in the blood of the cord of the newborns infected in UTERO by CMV, the compliance at one month the criteria of tolerance;   the compliance at one month;   the criteria of tolerance
91CompletedA Phase II Dose-Ranging, Open-Labelled Trial of Foscarnet Salvage Therapy for AIDS Patients With Sight-Threatening CMV Retinitis Who Cannot Be Treated With Ganciclovir Due To Myelosuppression or Treatment Failure
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Foscarnet sodium
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult
Phase:Phase II
Number Enrolled:156
Funded By:NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00000691
Other IDs:ACTG 093
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:August 1992
Acronym:
Primary Completion Date:
Outcome Measure:
92RecruitingDetermining a Viral Load Threshold for Treating Cytomegalovirus (CMV)
Condition:Cytomegalovirus
Interventions:Drug: ganciclovir treatment or monitoring of viral load.;   Other: Monitor or treat with ganciclovir
Sponsor:Royal Free Hampstead NHS Trust
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:178
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00947141
Other IDs:6077,   REC # 6077,   Royal Free R and D # 5219,   EudraCT 2007-003472-19
First Received Date:June 12, 2009
Start Date:February 2003
Completion Date:August 2011
Last Updated Date:July 27, 2010
Last Verified Date:July 2009
Acronym:
Primary Completion Date:February 2011
Outcome Measures:Group A # with low level of CMV who develop a viral load > 3000 copies/ml & Group B # who develop a 2nd episode of a viral load above 3000 copies/ml after therapy stopped.;   To define the duration of antiviral therapy needed to treat CMV viraemia. To record the rate of increase in viral load prior to starting preemptive therapy & to correlate viral loads with CMV specific immune function.
93CompletedDoes Normal Brain Imaging Predict Normal Neurodevelopmental Outcome in Fetuses With Proven Cytomegalovirus Infection?
Conditions:CMV;   Prenatal Diagnosis;   Ultrasound;   MRI
Intervention:
Sponsors:Wolfson Medical Center;   Shiba Medical Center;   Tel Aviv Medical Center
Gender:Both
Group:Child
Phase:
Number Enrolled:42
Funded By:Other
Study Type:Observational
Study Design:Observational Model: Case Control;   Time Perspective: Retrospective
NCT ID:NCT00872703
Other IDs:SR-907
First Received Date:March 30, 2009
Start Date:January 2008
Completion Date:February 2009
Last Updated Date:March 30, 2009
Last Verified Date:March 2009
Acronym:
Primary Completion Date:December 2008
Outcome Measure:neuropsychological outcome
94CompletedPhase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease
Conditions:HIV Infections;   Gastrointestinal Diseases
Intervention:Drug: Foscarnet sodium
Sponsor:Astra USA
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:145
Funded By:Industry
Study Type:Interventional
Study Design:Endpoint Classification: Efficacy Study;   Primary Purpose: Treatment
NCT ID:NCT00002145
Other IDs:020I,   93-FOS-29
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:March 1996
Acronym:
Primary Completion Date:
Outcome Measure:
95Unknown A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS Who Have Not Had Success With Ganciclovir
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Foscarnet sodium
Sponsor:Astra USA
Gender:Both
Group:Adult
Phase:
Number Enrolled:
Funded By:Industry
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00002301
Other IDs:020B,   88-FOS-02
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:March 1991
Acronym:
Primary Completion Date:
Outcome Measure:
96Not yet recruitingThe Maternal Cellular Immune System and Cytomegalovirus Intrauterine Infection
Condition:Cytomegalovirus Infections
Intervention:
Sponsor:Shaare Zedek Medical Center
Gender:Female
Group:Adult
Phase:
Number Enrolled:100
Funded By:Other
Study Type:Observational
Study Design:Observational Model: Case Control;   Time Perspective: Cross-Sectional
NCT ID:NCT01081379
Other IDs:Schlesinger - CMV
First Received Date:March 4, 2010
Start Date:April 2010
Completion Date:April 2013
Last Updated Date:March 4, 2010
Last Verified Date:March 2010
Acronym:
Primary Completion Date:April 2011
Outcome Measure:Maternal-Fetal transmission of CMV
97RecruitingImpact of Rituximab Induction and Living Donation on Immunoregulation and Virus Control in Renal Transplantation
Conditions:Kidney Transplantation;   Rituximab;   Living Donors;   Immunology;   Virus
Interventions:Drug: Rituximab;   Procedure: living donor transplantation;   Procedure: deceased donor transplantation
Sponsors:University of Giessen;   University Hospital Freiburg;   University of Heidelberg;   German Cancer Research Center;   Astellas Pharma US, Inc.;   Novartis
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:90
Funded By:Other / Industry
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT01136395
Other IDs:NTx-RTx-LD-001,   2009-012198-36
First Received Date:June 2, 2010
Start Date:January 2010
Completion Date:July 2018
Last Updated Date:June 2, 2010
Last Verified Date:June 2010
Acronym:
Primary Completion Date:April 2018
Outcome Measures:Impact of Rtx on immune parameters predictive of graft outcome including B cell responses;   Impact of living donation on immune parameters predictive of graft outcome including B cell responses;   Impact of Rtx on virus replication (EBV, CMV, BK/JC);   Impact of living donation on virus replication (EBV, CMV, BK/JC);   Patient and graft survival;   Graft function and proteinuria;   Incidence of acute rejection;   Incidence of chronic allograft dysfunction;   Incidence of severe infectious disease;   Incidence of malignancy;   Incidence of side effects associated with Rtx
98RecruitingVaccine Therapy in Preventing Cytomegalovirus in Healthy Participants
Condition:Nonneoplastic Condition
Interventions:Biological: PADRE-CMV fusion peptide vaccine;   Biological: tetanus-CMV fusion peptide vaccine;   Drug: agatolimod sodium
Sponsors:City of Hope Medical Center;   National Cancer Institute (NCI)
Gender:Both
Group:Adult
Phase:Phase I
Number Enrolled:96
Funded By:Other / NIH
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00722839
Other IDs:City of Hope 03121,   R01CA077544,   P30CA033572,   CHNMC-03121,   CDR0000599724
First Received Date:July 25, 2008
Start Date:December 2006
Completion Date:
Last Updated Date:March 24, 2011
Last Verified Date:March 2011
Acronym:
Primary Completion Date:September 2011
Outcome Measures:Successful completion of a series of 4 injections (at weeks 0, 3, 6, and 9) without dose-limiting toxicity;   Maximum tolerated dose of each vaccine with or without adjuvant CpG 7909;   Number of CMV-positive and CMV-specific CD8+ T cells/L
99CompletedCMV Retinitis Retreatment Trial
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Interventions:Drug: Foscarnet sodium;   Drug: Ganciclovir
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:300
Funded By:NIH
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Primary Purpose: Treatment
NCT ID:NCT00000766
Other IDs:ACTG 228
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:February 28, 2011
Last Verified Date:February 2011
Acronym:
Primary Completion Date:September 1995
Outcome Measure:
100CompletedA Randomized, Phase I/II Trial to Assess the Safety and Antiviral Effects of Escalating Doses of A Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Viremia and/or Viruria
Conditions:Cytomegalovirus Infections;   HIV Infections
Intervention:Drug: Sevirumab
Sponsor:Sandoz Inc.
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:
Funded By:Industry
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00002268
Other IDs:071A,   Study No B102
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:December 1991
Acronym:
Primary Completion Date:
Outcome Measure:

RankStatusStudy
101CompletedResponse of Older Adults to Influenza Vaccination With Regard to Cytomegalovirus (CMV) Status
Condition:Influenza
Intervention:Biological: Fluarix
Sponsors:Health Protection Agency, United Kingdom;   Royal Free and University College Medical School
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:100
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT00442975
Other IDs:CMVfluvaccinees,   EudraCT No: 2006-006563-23
First Received Date:March 2, 2007
Start Date:March 2007
Completion Date:September 2007
Last Updated Date:July 9, 2008
Last Verified Date:February 2008
Acronym:CMVflu
Primary Completion Date:
Outcome Measure:Response to influenza vaccination (HI)
102CompletedComparison of Two Test Methods-NASBA and Antigenemia-for Detecting Cytomegalovirus Infection
Conditions:Cytomegalovirus Infection;   Infection
Intervention:
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:
Number Enrolled:180
Funded By:NIH
Study Type:Observational
Study Design:
NCT ID:NCT00001976
Other IDs:000059,   00-I-0059
First Received Date:January 20, 2000
Start Date:January 2000
Completion Date:February 2003
Last Updated Date:March 3, 2008
Last Verified Date:February 2003
Acronym:
Primary Completion Date:
Outcome Measure:
103CompletedArtesunate in Preemptive Treatment of Human Cytomegalovirus (CMV) in Stem Cell Transplant Recipients
Condition:Cytomegalovirus Infections
Intervention:Drug: Artesunate
Sponsors:Hadassah Medical Organization;   Institut für Klinische und Molekulare Virologie;   University of Erlangen-Nürnberg Medical School
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:20
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00284687
Other IDs:MYS-02-HMO-CTIL
First Received Date:January 31, 2006
Start Date:July 2006
Completion Date:March 2010
Last Updated Date:June 9, 2010
Last Verified Date:August 2009
Acronym:
Primary Completion Date:March 2010
Outcome Measures:Safety;   Efficacy
104CompletedThe Influence of Intensive Education and Coaching on Compliance for Oral Ganciclovir in the Prophylaxis of CMV: an Open Randomised Trial
Condition:Cytomegalovirus Infections
Intervention:Behavioral: instructions and coaching
Sponsors:University Hospital, Ghent;   Hoffmann-La Roche
Gender:Both
Group:Adult
Phase:
Number Enrolled:21
Funded By:Other / Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
NCT ID:NCT00566072
Other IDs:2001/181
First Received Date:November 30, 2007
Start Date:May 2001
Completion Date:May 2003
Last Updated Date:December 4, 2007
Last Verified Date:December 2007
Acronym:
Primary Completion Date:
Outcome Measures:relation between compliance of medication towards chemoprophylaxis and occurrence of CMV infection after kidney transplantation;   relation between compliance and the instructions which a patient gets about intake of medication
105CompletedHPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Interventions:Drug: Cidofovir;   Drug: Probenecid
Sponsors:National Institute of Allergy and Infectious Diseases (NIAID);   Gilead Sciences
Gender:Both
Age Groups:Child / Adult / Senior
Phase:
Number Enrolled:100
Funded By:NIH / Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety Study;   Primary Purpose: Treatment
NCT ID:NCT00000799
Other IDs:ACTG 281,   GS-93-105,   FDA 231A
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:March 1996
Acronym:
Primary Completion Date:
Outcome Measure:
106CompletedAn Open Study of Foscarnet Treatment First Episode CMV-Retinitis in AIDS Patients
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Foscarnet sodium
Sponsor:Astra USA
Gender:Both
Group:Adult
Phase:
Number Enrolled:
Funded By:Industry
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00002039
Other IDs:020A,   88-FOS-01
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:March 1991
Acronym:
Primary Completion Date:
Outcome Measure:
107CompletedAn Open-Label Safety Study of Oral Ganciclovir Maintenance Treatment of CMV Retinitis in People With Limited Venous Access
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Ganciclovir
Sponsor:Hoffmann-La Roche
Gender:Both
Age Groups:Child / Adult / Senior
Phase:
Number Enrolled:
Funded By:Industry
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Primary Purpose: Treatment
NCT ID:NCT00002135
Other IDs:037C,   GANS2224
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:November 1995
Acronym:
Primary Completion Date:
Outcome Measure:
108CompletedA Comparison of ISIS 2922 Used Immediately or Later in Patients With Cytomegalovirus (CMV) of the Eyes
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Fomivirsen sodium
Sponsor:Isis Pharmaceuticals
Gender:Both
Age Groups:Adult / Senior
Phase:
Number Enrolled:60
Funded By:Industry
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Primary Purpose: Treatment
NCT ID:NCT00002355
Other IDs:251A,   ISIS 2922-CS2
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:July 1998
Acronym:
Primary Completion Date:
Outcome Measure:
109CompletedA Phase I Study of the Safety of Proleukin (Aldesleukin) in Combination With Ganciclovir and Antiretroviral Therapy in HIV Seropositive Patients With Cytomegalovirus (CMV) Retinitis
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Aldesleukin
Sponsor:Chiron Corporation
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:
Funded By:Industry
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Primary Purpose: Treatment
NCT ID:NCT00002321
Other IDs:086A,   CS-L293-10
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:October 1994
Acronym:
Primary Completion Date:
Outcome Measure:
110CompletedA Pilot Study to Obtain Preliminary Information Regarding the Efficacy and Safety of the Combination of Immune Globulin and Ganciclovir as Compared to Ganciclovir Alone in the Treatment of Sight-Threatening CMV Retinitis in Patients With AIDS
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Interventions:Drug: Globulin, Immune;   Drug: Ganciclovir
Sponsor:American National Red Cross
Gender:Both
Age Groups:Adult / Senior
Phase:
Number Enrolled:
Funded By:Other
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00001999
Other IDs:079A,   219-90
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:April 1993
Acronym:
Primary Completion Date:
Outcome Measure:
111RecruitingAdministration of Rapidly Generated Multivirus-specific Cytotoxic T-Lymphocytes (VIRAGE)
Conditions:CML;   Adenovirus Infection
Intervention:Biological: Infusion of CTL lines
Sponsor:Baylor College of Medicine
Gender:Both
Age Groups:Child / Adult / Senior
Phase:
Number Enrolled:28
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT01070797
Other IDs:26374-VIRAGE
First Received Date:February 16, 2010
Start Date:January 2011
Completion Date:February 2015
Last Updated Date:March 4, 2011
Last Verified Date:March 2011
Acronym:
Primary Completion Date:February 2015
Outcome Measures:The primary objective is to determine the feasibility and safety of administering rapidly generated donor-derived multivirus-specific CTLs to mediate antiviral activity in HSCT recipients.;   Secondary objectives are to determine the effect of rCTL infusion on viral load.;   Reconstitution of antiviral immunity post-infusion;   Clinical response
112CompletedGene Therapy and Surgery Followed by Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Cancer of the Mouth or Throat
Condition:Head and Neck Cancer
Interventions:Biological: Ad5CMV-p53 gene;   Drug: cisplatin;   Procedure: conventional surgery;   Radiation: radiation therapy
Sponsors:Southwest Oncology Group;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:60
Funded By:Other / NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00017173
Other IDs:CDR0000068658,   SWOG-S0011
First Received Date:June 6, 2001
Start Date:February 2003
Completion Date:
Last Updated Date:February 6, 2009
Last Verified Date:May 2006
Acronym:
Primary Completion Date:March 2008
Outcome Measures:Feasibility of treatment as measured by accrual rate and percentage of patients successfully receiving the required doses of study treatment to the primary site;   Progression-free survival from time of registration until disease progression;   Overall survival from time of registration until death from any cause;   Local control assessed from time of registration until disease progression within 2 cm of initial primary/nodal disease;   Toxicity of Ad5CMV-p53 gene (INGN 201) and chemoradiation assessed from time of registration until 30 days after completion of study treatment
113TerminatedMICI-CMV:Valganciclovir in Recurrent Bouts of Cryptogenic Inflammatory Bowel Diseases With an Infection by Cytomegalovirus
Conditions:Cytomegalovirus Infections;   Inflammatory Bowel Diseases
Intervention:Drug: Valganciclovir
Sponsor:University Hospital, Grenoble
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:40
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
NCT ID:NCT00237653
Other IDs:DCIC 03 21
First Received Date:October 11, 2005
Start Date:February 2004
Completion Date:December 2007
Last Updated Date:April 2, 2009
Last Verified Date:April 2009
Acronym:
Primary Completion Date:
Outcome Measures:Improvement of Crohns disease activity index score;   Diminution or disappearance of gravity criteria;   Endoscopy: improvement in appearance of lesions, or healing;   Anatomopathology: improvement of histological criteria, or total regression;   Anatomopathology: disappearance of viral infection criteria;   Virology: reversal of CMV IgG serology and PCR results
114RecruitingNilotinib for Cytomegalovirus Prophylaxis and Treatment After Allogeneic Hematopoietic Stem Cell Transplantation
Condition:Patients Who Have Received Allo-HSCT
Intervention:Drug: nilotinib
Sponsor:National Taiwan University Hospital
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:36
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT01252017
Other IDs:201006057M
First Received Date:November 24, 2010
Start Date:November 2010
Completion Date:December 2012
Last Updated Date:November 30, 2010
Last Verified Date:November 2010
Acronym:
Primary Completion Date:June 2012
Outcome Measures:CMV-free rate;   Successful salvage rate
115RecruitingCytomegalovirus Cell-Mediated Immunity
Condition:Cytomegalovirus Infections
Intervention:
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Female
Group:Child
Phase:
Number Enrolled:200
Funded By:NIH
Study Type:Observational
Study Design:Observational Model: Case Control;   Time Perspective: Prospective
NCT ID:NCT00815165
Other IDs:06-0043,   N01AI80007C
First Received Date:December 26, 2008
Start Date:January 2009
Completion Date:December 2010
Last Updated Date:August 26, 2010
Last Verified Date:September 2009
Acronym:
Primary Completion Date:July 2010
Outcome Measure:Immunogenicity based on cytomegalovirus (CMV) specific cell-mediated immunity.
116CompletedSeroprevalence Study of Hepatitis A, Varicella-Zoster, Cytomegalovirus, Herpes Simplex and Bordetella Pertussis
Conditions:Viral Hepatitis Vaccines;   Hepatitis A;   Cytomegalovirus;   Varicella-Zoster Virus;   Bordetella Pertussis Infection;   Herpes Simplex (1 and 2)
Intervention:Other: Serum sample
Sponsor:GlaxoSmithKline
Gender:Both
Age Groups:Child / Adult / Senior
Phase:
Number Enrolled:3658
Funded By:Industry
Study Type:Observational
Study Design:Time Perspective: Prospective
NCT ID:NCT01160081
Other IDs:113564
First Received Date:July 8, 2010
Start Date:March 2010
Completion Date:September 2010
Last Updated Date:January 22, 2011
Last Verified Date:November 2010
Acronym:
Primary Completion Date:September 2010
Outcome Measures:Anti-HAV seropositivity status: Subjects with anti-HAV antibody titers >= assay cut-off.;   Anti-Pertussis Toxin seropositivity status for IgG and IgA: Subjects with anti-Pertussis Toxin antibody titers >= assay cut-off for IgG, Subjects with anti-Pertussis Toxin antibody titers >= assay cut-off for IgA;   Anti-VZV seropositivity status: Subjects with anti-VZV antibody titers >= assay cut-off;   Anti-CMV seropositivity status: Subjects with anti-CMV antibody titers >= assay cut-off;   Anti-HSV seropositivity status (defined as the percentage of subjects with anti-HSV 1 and 2 titers >= assay cut-off): Subjects with anti-HSV antibody titers >= assay cut-off;   Difference in HAV, VZV, CMV , HSV and BP seropositivity rates according to socioeconomic status, age group, gender, region, risk group, area and pertussis vaccination status (only for BP analysis)
117RecruitingPrevention of Transplant Atherosclerosis With Everolimus and Anti-cytomegalovirus Therapy
Conditions:Heart Transplantation;   Cardiac Allograft Vasculopathy;   Cytomegalovirus Infection
Interventions:Drug: Pre-emptive strategy with valganciclovir plus everolimus;   Drug: Prophylaxis with valganciclovir plus mycophenolate;   Drug: Prophylaxis with valganciclovir plus everolimus;   Drug: Pre-emptive mycophenolate
Sponsor:University of Bologna
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:100
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT00966836
Other IDs:PROTECT 2008-006980-35
First Received Date:August 26, 2009
Start Date:April 2009
Completion Date:
Last Updated Date:August 26, 2009
Last Verified Date:August 2009
Acronym:PROTECT
Primary Completion Date:April 2012
Outcome Measures:Change in maximal intimal thickness;   CMV infection
118RecruitingImmune Response and Cytomegalovirus in Intensive Care Unit (ICU) Patients
Condition:Cytomegalovirus Infection
Intervention:Other: Sampling of blood, phenotypic analysis sub-populations NK by cytometric of stream in multiple markings
Sponsor:Assistance Publique Hopitaux De Marseille
Gender:Both
Age Groups:Adult / Senior
Phase:
Number Enrolled:65
Funded By:Other
Study Type:Interventional
Study Design:Intervention Model: Parallel Assignment;   Masking: Open Label
NCT ID:NCT00699868
Other IDs:2007-A01197-46
First Received Date:June 13, 2008
Start Date:March 2008
Completion Date:August 2011
Last Updated Date:January 26, 2010
Last Verified Date:January 2010
Acronym:2006/25
Primary Completion Date:January 2011
Outcome Measures:Bring to light the quantitative and qualitative immunological modifications of the present cells NK before the arisen of an infection to CMV;   Bring to light the quantitative and qualitative immunological modifications of cells NK in the consequences of an infectious shock
119CompletedRisk Factors for Cytomegalovirus Disease in Solid Organ Transplantation
Conditions:Transplantation;   Infection;   Cytomegalovirus Infections
Intervention:
Sponsors:Mayo Clinic;   Roche Pharma AG
Gender:Both
Age Groups:Adult / Senior
Phase:
Number Enrolled:500
Funded By:Other / Industry
Study Type:Observational
Study Design:Time Perspective: Retrospective
NCT ID:NCT00170170
Other IDs:2275-04,   VAL101
First Received Date:September 13, 2005
Start Date:November 2004
Completion Date:June 2007
Last Updated Date:February 1, 2010
Last Verified Date:February 2010
Acronym:
Primary Completion Date:June 2007
Outcome Measure:
120Unknown Valganciclovir to Reduce T Cell Activation in HIV Infection
Conditions:HIV Infections;   Cytomegalovirus Infections
Intervention:Drug: valganciclovir 900mg daily vs. placebo x 8 weeks
Sponsor:University of California, San Francisco
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:30
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
NCT ID:NCT00264290
Other IDs:H10775-26933-01,   SFGH GCRC #976,   5 P30 AI 27763 - Hunt,   Roche VAL 104
First Received Date:December 9, 2005
Start Date:August 2006
Completion Date:March 2008
Last Updated Date:April 17, 2007
Last Verified Date:September 2006
Acronym:
Primary Completion Date:
Outcome Measures:Change in T cell activation at week 8.;   Change in CMV-specific T cell responses at week 8.;   Change in CMV DNA shedding at week 8.;   Change in CD4 counts and plasma HIV RNA levels at week 8.;   Change in all of the above factors after a 4-week washout period

RankStatusStudy
121CompletedThe Safety and Effectiveness of FIAC in the Treatment of Cytomegalovirus (CMV) in Patients With AIDS
Conditions:Cytomegalovirus Infections;   HIV Infections
Intervention:Drug: Fiacitabine
Sponsors:National Institute of Allergy and Infectious Diseases (NIAID);   Oclassen Pharmaceuticals
Gender:Both
Age Groups:Child / Adult
Phase:Phase II
Number Enrolled:78
Funded By:NIH / Industry
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00000981
Other IDs:ACTG 122 FIAC,   R89-001-01, 02, 03, 04
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:July 1992
Acronym:
Primary Completion Date:
Outcome Measure:
122CompletedPhase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Interventions:Drug: Sargramostim;   Drug: Ganciclovir
Sponsor:Schering-Plough
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:
Funded By:Industry
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00002070
Other IDs:005A,   C88-059
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:May 1991
Acronym:
Primary Completion Date:
Outcome Measure:
123CompletedThe Safety and Effectiveness of Ganciclovir Used Alone or in Combination With Granulocyte-Macrophage Colony Stimulating Factor in the Treatment of Cytomegalovirus (CMV) of the Eye in Patients With AIDS
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Interventions:Drug: Zidovudine;   Drug: Sargramostim;   Drug: Ganciclovir
Sponsors:National Institute of Allergy and Infectious Diseases (NIAID);   Schering-Plough;   Hoffmann-La Roche
Gender:Both
Age Groups:Child / Adult
Phase:
Number Enrolled:50
Funded By:NIH / Industry
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
NCT ID:NCT00000989
Other IDs:ACTG 073
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:March 11, 2011
Last Verified Date:August 1992
Acronym:
Primary Completion Date:July 1992
Outcome Measure:
124RecruitingShort-Term vs. Long-Term Valganciclovir Therapy for Symptomatic Congenital CMV Infections
Condition:Cytomegalovirus Infections
Interventions:Drug: Valganciclovir;   Drug: Placebo
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Group:Child
Phase:Phase III
Number Enrolled:104
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
NCT ID:NCT00466817
Other IDs:06-0046,   CASG 112,   N01AI30025C
First Received Date:April 26, 2007
Start Date:June 2008
Completion Date:April 2014
Last Updated Date:March 24, 2011
Last Verified Date:June 2010
Acronym:
Primary Completion Date:April 2012
Outcome Measures:Change in best ear hearing assessments.;   Adverse events which lead to permanent discontinuation of valganciclovir therapy or to irreversible outcome of the adverse event.;   Neurological impairment utilizing the Bayley Scales of Infant and Toddler Development.;   Maximum change in hearing assessments over left and right ears.;   Hearing deterioration over left and right ears.
125CompletedThe Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Interventions:Drug: Cidofovir;   Drug: Probenecid
Sponsor:Gilead Sciences
Gender:Both
Age Groups:Child / Adult
Phase:Phase II
Number Enrolled:48
Funded By:Industry
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Primary Purpose: Treatment
NCT ID:NCT00002437
Other IDs:216A,   GS-93-106
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:November 1994
Acronym:
Primary Completion Date:
Outcome Measure:
126CompletedImmune Activity Against CVM Retinitis
Conditions:Acquired Immunodeficiency Syndrome;   Cytomegalovirus Retinitis;   HIV Infection
Intervention:
Sponsor:National Eye Institute (NEI)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:
Number Enrolled:15
Funded By:NIH
Study Type:Observational
Study Design:
NCT ID:NCT00001611
Other IDs:970081,   97-EI-0081
First Received Date:November 3, 1999
Start Date:February 1997
Completion Date:April 2004
Last Updated Date:March 3, 2008
Last Verified Date:April 2004
Acronym:
Primary Completion Date:
Outcome Measure:
127CompletedTrial of Preemptive Treatment With Oral Valganciclovir Compared With Intravenous (IV) Ganciclovir for Cytomegalovirus Infection After Bone Marrow or Peripheral Blood Stem Cell Transplant
Condition:Cytomegalovirus Infections
Interventions:Drug: Oral Valganciclovir;   Drug: IV Ganciclovir
Sponsor:Washington University School of Medicine
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:120
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00241345
Other IDs:04-0274
First Received Date:October 17, 2005
Start Date:March 2004
Completion Date:February 2008
Last Updated Date:February 3, 2009
Last Verified Date:February 2009
Acronym:
Primary Completion Date:
Outcome Measures:The study end point for statistical purposes will be clearance of CMV viremia at 4 weeks from the start of therapy. Clearance of CMV viremia will be defined as a CMV viral load less than 5,000 copies/ml of whole blood.;   All patients will be followed for 6 months after randomization.
128CompletedA Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Foscarnet sodium
Sponsor:Astra USA
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:112
Funded By:Industry
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00002125
Other IDs:020H,   93-FOS-31
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:June 1997
Acronym:
Primary Completion Date:
Outcome Measure:
129CompletedA Study of Foscarnet Plus Ganciclovir in the Treatment of Cytomegalovirus of the Eye in Patients With AIDS Who Have Already Been Treated With Ganciclovir
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Interventions:Drug: Foscarnet sodium;   Drug: Ganciclovir
Sponsors:National Institute of Allergy and Infectious Diseases (NIAID);   Astra USA;   Hoffmann-La Roche
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:30
Funded By:NIH / Industry
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00000970
Other IDs:ACTG 151
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:July 31, 2008
Last Verified Date:October 1994
Acronym:
Primary Completion Date:
Outcome Measure:
130CompletedStudies of the Ocular Complications of AIDS (SOCA)--Monoclonal Antibody CMV Retinitis Trial (MACRT)
Conditions:HIV Infections;   Cytomegalovirus Retinitis
Intervention:Drug: MSL-109
Sponsor:National Eye Institute (NEI)
Gender:Both
Age Groups:Child / Adult / Senior
Phases:Phase II / Phase III
Number Enrolled:
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Primary Purpose: Treatment
NCT ID:NCT00000135
Other IDs:NEI-34
First Received Date:September 23, 1999
Start Date:September 1995
Completion Date:August 1996
Last Updated Date:September 16, 2009
Last Verified Date:September 2009
Acronym:
Primary Completion Date:
Outcome Measure:
131CompletedA Study of Valganciclovir in the Treatment of Cytomegalovirus (CMV) Retinitis in Patients With AIDS
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Valganciclovir
Sponsor:Hoffmann-La Roche
Gender:Both
Age Groups:Adult / Senior
Phase:
Number Enrolled:200
Funded By:Industry
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00002222
Other IDs:268B
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:April 1999
Acronym:
Primary Completion Date:
Outcome Measure:
132CompletedComparison of Two Methods in the Treatment of Cytomegalovirus of the Eyes in Patients With AIDS
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Interventions:Drug: Sevirumab;   Drug: Foscarnet sodium;   Drug: Ganciclovir
Sponsors:National Institute of Allergy and Infectious Diseases (NIAID);   Facet Biotech
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase II
Number Enrolled:167
Funded By:NIH / Industry
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00001061
Other IDs:ACTG 266
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:February 28, 2011
Last Verified Date:February 2011
Acronym:
Primary Completion Date:March 1998
Outcome Measure:
133Unknown Evaluation of Interferon-Gamma Responses to HCMV Infection in HIV Positive Individuals
Conditions:HIV Infection;   CMV Disease
Intervention:
Sponsors:The Alfred;   Cellestis
Gender:Both
Age Groups:Adult / Senior
Phase:
Number Enrolled:20
Funded By:Other / Industry
Study Type:Observational
Study Design:Observational Model: Cohort;   Time Perspective: Prospective
NCT ID:NCT00168259
Other IDs:185/04
First Received Date:September 13, 2005
Start Date:December 2004
Completion Date:
Last Updated Date:May 16, 2008
Last Verified Date:May 2008
Acronym:
Primary Completion Date:
Outcome Measure:
134CompletedA Comparison of Valganciclovir and Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Interventions:Drug: Valganciclovir;   Drug: Ganciclovir
Sponsor:Hoffmann-La Roche
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:
Funded By:Industry
Study Type:Interventional
Study Design:Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
NCT ID:NCT00002377
Other IDs:WV15376
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:July 1, 2005
Last Verified Date:July 2005
Acronym:
Primary Completion Date:
Outcome Measure:
135CompletedStem Cell Transplant, Chemotherapy, and Biological Therapy in Treating Patients With High-Risk or Refractory Multiple Myeloma
Condition:Multiple Myeloma and Plasma Cell Neoplasm
Interventions:Biological: CMV pp65 peptide;   Biological: hTERT I540/R572Y/D988Y multipeptide vaccine;   Biological: pneumococcal polyvalent vaccine;   Biological: survivin Sur1M2 peptide vaccine
Sponsors:University of Maryland Greenebaum Cancer Center;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:56
Funded By:Other / NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00499577
Other IDs:CDR0000552988,   MSGCC-0610-GCC,   UPCC-0610-GCC
First Received Date:July 10, 2007
Start Date:December 2006
Completion Date:
Last Updated Date:February 26, 2011
Last Verified Date:August 2009
Acronym:
Primary Completion Date:February 2009
Outcome Measures:Toxicity at 21 and 28 days post-transplant;   T-cell responses against the hTERT vaccine as measured by tetramer assays at 100 days post-transplant;   Paraprotein levels in the blood or urine and serum free light chain analyses at 60 days and at 6 months post-transplant;   Cytotoxic T-cell responses against autologous myeloma cell at day 100 post-transplant via chromium-51 release or flow-based assays;   Maximum clinical response;   1 and 2-year event-free survival;   Overall survival rates;   CD4 and CD8 T-cell responses against cytomegalovirus (CMV) at days 60 and 100 post-transplantation by CFSE dye dilution assays;   Composite binding antibody responses at days 60 and day 100 post-transplant by ELISA
136CompletedHigh-Frequency Oscillatory Ventilation Associated With Inhaled Nitric Oxide in Children
Condition:Acute Hypoxemic Respiratory Failure
Intervention:Procedure: High frequency oscillatory ventilation
Sponsor:UPECLIN HC FM Botucatu Unesp
Gender:Both
Group:Child
Phase:Phase III
Number Enrolled:24
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
NCT ID:NCT00924846
Other IDs:upeclin/HC/FMB-Unesp-26
First Received Date:June 18, 2009
Start Date:April 2005
Completion Date:June 2009
Last Updated Date:June 19, 2009
Last Verified Date:June 2009
Acronym:
Primary Completion Date:April 2008
Outcome Measure:Oxygenation indexes
137RecruitingDonor Lymphocytes in Preventing and Treating Cytomegalovirus Infection or Adenovirus Infection in Patients Who Have Undergone Umbilical Cord Blood Transplant
Condition:Cancer
Interventions:Biological: allogeneic CMV/AdV-specific cytotoxic T lymphocytes;   Other: laboratory biomarker analysis
Sponsors:Baylor College of Medicine;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:18
Funded By:Other / NIH
Study Type:Interventional
Study Design:Primary Purpose: Supportive Care
NCT ID:NCT01017705
Other IDs:CDR0000659669,   BCM-H-23668
First Received Date:November 20, 2009
Start Date:November 2009
Completion Date:
Last Updated Date:April 9, 2010
Last Verified Date:December 2009
Acronym:
Primary Completion Date:March 2011
Outcome Measures:Safety of cytotoxic T-cell lymphocytes (CTL) as assessed by CTEP Active version of the NCI CTCAE at 30-45 days after CTL infusion;   Viral load of cytomegalovirus and adenovirus as assessed by PCR before CTL infusion and then weekly for up to 60 days after CTL infusion;   Reconstitution of antiviral immunity as assessed by ELISPOT assays or tetramer assays;   Systemic infections occurring within 6 months of CTL infusion;   Secondary graft failure as assessed for 30 days after CTL infusion
138Unknown Safety Study of Mini-Dystrophin Gene to Treat Duchenne Muscular Dystrophy
Condition:Duchenne Muscular Dystrophy
Intervention:Genetic: rAAV vector expressing Mini-Dystrophin with CMV promoter
Sponsors:Nationwide Children's Hospital;   Asklepios Biopharmaceutical Inc.
Gender:Male
Group:Child
Phase:Phase I
Number Enrolled:6
Funded By:Other / Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
NCT ID:NCT00428935
Other IDs:CCRI IRB05-00118
First Received Date:January 26, 2007
Start Date:March 2006
Completion Date:December 2008
Last Updated Date:March 18, 2007
Last Verified Date:March 2007
Acronym:
Primary Completion Date:
Outcome Measures:Safety;   mini-dystrophin gene expression at the site of gene transfer;   muscle strength evaluated by Maximal Volume Isometric Contraction Testing
139Not yet recruitingThe Benefits Feasibility and Acceptability of Extended Screening Testing in Newborn Babies Who Are Referred for Further Hearing Assessment
Conditions:Hearing Loss;   Cytomegalovirus
Intervention:Other: Screening urine and saliva tests for congenital Cytomegalovirus
Sponsor:Newcastle-upon-Tyne Hospitals NHS Trust
Gender:Both
Group:Child
Phase:
Number Enrolled:800
Funded By:Other
Study Type:Observational
Study Design:Observational Model: Cohort;   Time Perspective: Prospective
NCT ID:NCT01162330
Other IDs:5286,   10/H0904/25
First Received Date:July 13, 2010
Start Date:August 2010
Completion Date:
Last Updated Date:July 13, 2010
Last Verified Date:July 2010
Acronym:BEST
Primary Completion Date:
Outcome Measures:Feasibility of targeted screening for congenital CMV;   Acceptability of extended screening tests;   Clinical utility of extended screening tests
140CompletedChemotherapy Combined With Gene Therapy in Treating Patients Who Have Stage III or Stage IV Breast Cancer
Condition:Breast Cancer
Interventions:Biological: Ad5CMV-p53 gene;   Drug: docetaxel;   Drug: doxorubicin hydrochloride;   Procedure: conventional surgery;   Procedure: neoadjuvant therapy
Sponsor:Introgen Therapeutics
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:
Funded By:Industry
Study Type:Interventional
Study Design:Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00044993
Other IDs:CDR0000256223,   INTROGEN-201-010,   MDA-ID-00008
First Received Date:September 6, 2002
Start Date:February 2002
Completion Date:
Last Updated Date:February 6, 2009
Last Verified Date:July 2004
Acronym:
Primary Completion Date:
Outcome Measure:

RankStatusStudy
141Active, not recruitingGanciclovir by Infusion and by Mouth in Treating Patients With Cytomegalovirus After Donor Bone Marrow Transplant
Conditions:Chronic Myeloproliferative Disorders;   Leukemia;   Lymphoma;   Multiple Myeloma and Plasma Cell Neoplasm;   Myelodysplastic Syndromes;   Myelodysplastic/Myeloproliferative Diseases
Interventions:Drug: ganciclovir;   Other: pharmacological study;   Procedure: allogeneic hematopoietic stem cell transplantation
Sponsors:City of Hope Medical Center;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:24
Funded By:Other / NIH
Study Type:Interventional
Study Design:Primary Purpose: Supportive Care
NCT ID:NCT00530218
Other IDs:CDR0000564546,   P30CA033572,   CHNMC-98074
First Received Date:September 13, 2007
Start Date:March 1999
Completion Date:
Last Updated Date:January 11, 2010
Last Verified Date:January 2010
Acronym:
Primary Completion Date:December 2012
Outcome Measures:Patient compliance with an oral ganciclovir (GCV) regimen following induction with IV GCV as measured by a self-recorded patient diary and number of adverse events;   Observation of cytomegalovirus (CMV) in blood as measured by either blood culture or polymerase chain reaction (PCR) during the course of antiviral treatment;   Rate of CMV-associated disease that occurs during or after treatment;   Rate of CMV blood infection that occurs after treatment and during the period to day 180;   GCV blood levels;   Correlation of the GCV pharmacokinetic data with clinical outcome;   Practical ability to utilize PCR-based decisions
142Unknown Vaccine Therapy in Treating Patients Who Have Undergone a Donor Stem Cell Transplant and Have Cytomegalovirus Infection That Has Not Responded to Therapy
Condition:Cancer
Interventions:Biological: cytomegalovirus pp65-specific cytotoxic T lymphocytes;   Genetic: polymerase chain reaction;   Other: flow cytometry;   Other: immunologic technique;   Other: laboratory biomarker analysis
Sponsor:Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:20
Funded By:Other
Study Type:Interventional
Study Design:Masking: Open Label;   Primary Purpose: Supportive Care
NCT ID:NCT00509691
Other IDs:CDR0000557037,   PSCI-25114
First Received Date:July 30, 2007
Start Date:June 2007
Completion Date:
Last Updated Date:September 16, 2010
Last Verified Date:October 2007
Acronym:
Primary Completion Date:
Outcome Measures:Toxicity;   Treatment failure;   Safety;   Time to development of cytomegalovirus (CMV) specific immune reconstitution;   CMV DNA levels;   Time during post-infusion follow up at which the dominant CMV pp65 epitope for the donor is recognized by the cytotoxic t-cell lymphocyte recipient
143Unknown Cytomegalovirus (CMV) Infection in Pregnancy
Conditions:Pregnancy Complications;   Cytomegalovirus Infection
Intervention:
Sponsor:University of Pennsylvania
Gender:Female
Age Groups:Child / Adult / Senior
Phase:
Number Enrolled:220
Funded By:Other
Study Type:Observational
Study Design:Observational Model: Case Control;   Time Perspective: Cross-Sectional;   Time Perspective: Retrospective/Prospective
NCT ID:NCT00194155
Other IDs:R01 17625-03-13
First Received Date:September 12, 2005
Start Date:May 2003
Completion Date:May 2008
Last Updated Date:August 27, 2007
Last Verified Date:August 2007
Acronym:
Primary Completion Date:
Outcome Measure:
144Unknown Cytomegalovirus (CMV) Infection in Amniotic Fluid
Conditions:Pregnancy Complications;   Cytomegalovirus Infections
Intervention:
Sponsor:University of Pennsylvania
Gender:Female
Age Groups:Child / Adult
Phase:
Number Enrolled:300
Funded By:Other
Study Type:Observational
Study Design:Observational Model: Case Control;   Time Perspective: Cross-Sectional;   Time Perspective: Retrospective/Prospective
NCT ID:NCT00194142
Other IDs:803583,   R01 17625-03-14
First Received Date:September 12, 2005
Start Date:July 2007
Completion Date:
Last Updated Date:June 6, 2007
Last Verified Date:May 2007
Acronym:
Primary Completion Date:
Outcome Measure:
145CompletedStudies of the Ocular Complications of AIDS (SOCA)--Foscarnet-Ganciclovir CMV Retinitis Trial (FGCRT)
Conditions:HIV Infections;   Cytomegalovirus Retinitis
Interventions:Drug: Foscarnet;   Drug: Ganciclovir
Sponsor:National Eye Institute (NEI)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Primary Purpose: Treatment
NCT ID:NCT00000136
Other IDs:NEI-35
First Received Date:September 23, 1999
Start Date:March 1990
Completion Date:October 1991
Last Updated Date:September 16, 2009
Last Verified Date:September 2009
Acronym:
Primary Completion Date:
Outcome Measure:
146CompletedStudies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT)
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Interventions:Device: Ganciclovir Intraocular Device;   Drug: Ganciclovir;   Drug: Cidofovir
Sponsor:National Eye Institute (NEI)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Primary Purpose: Treatment
NCT ID:NCT00000143
Other IDs:NEI-42
First Received Date:September 23, 1999
Start Date:May 1997
Completion Date:
Last Updated Date:March 18, 2010
Last Verified Date:September 2009
Acronym:
Primary Completion Date:
Outcome Measure:
147CompletedA Study of AZT Plus Ganciclovir in Patients With AIDS and Cytomegalovirus (CMV) Infection
Conditions:Cytomegalovirus Infections;   HIV Infections
Interventions:Drug: Zidovudine;   Drug: Ganciclovir
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Adult / Senior
Phase:
Number Enrolled:60
Funded By:NIH
Study Type:Interventional
Study Design:Endpoint Classification: Pharmacokinetics Study;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00000995
Other IDs:ACTG 004
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:August 25, 2008
Last Verified Date:September 2002
Acronym:
Primary Completion Date:
Outcome Measure:
148CompletedThe Safety and Effectiveness of ISIS 2922 in Patients With AIDS Who Have Cytomegalovirus (CMV) of the Eyes
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Fomivirsen sodium
Sponsor:Isis Pharmaceuticals
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:
Funded By:Industry
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00002356
Other IDs:251C,   ISIS 2922-CS7
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:December 1998
Acronym:
Primary Completion Date:
Outcome Measure:
149CompletedA Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Ganciclovir
Sponsor:Roche Global Development
Gender:Both
Age Groups:Child / Adult / Senior
Phase:
Number Enrolled:280
Funded By:Other
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Primary Purpose: Treatment
NCT ID:NCT00002330
Other IDs:059F,   GANs2226
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:April 1996
Acronym:
Primary Completion Date:
Outcome Measure:
150CompletedGene Therapy in Preventing Cancer in Patients With Premalignant Carcinoma of the Oral Cavity or Pharynx
Condition:Head and Neck Cancer
Intervention:Biological: Ad5CMV-p53 gene
Sponsors:M.D. Anderson Cancer Center;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:51
Funded By:Other / NIH
Study Type:Interventional
Study Design:Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT00064103
Other IDs:CDR0000306522,   MDA-ID-00193,   NCI-6053
First Received Date:July 8, 2003
Start Date:June 2006
Completion Date:
Last Updated Date:March 2, 2011
Last Verified Date:January 2007
Acronym:
Primary Completion Date:
Outcome Measures:Safety at weeks 2-4 and then for 6 months;   Maximum tolerated dose of Ad5CMV-p53 gene administered as an oral rinse at weeks 2-4 and then for 6 months;   Transduction and efficiency of treatment as measured by Simon's optimal 2-stage design at weeks 2-4 and then for 6 months;   Effect of p53 gene transfer on molecular biomarkers of p53 activity reduction as measured by immunohistochemical staining at baseline and during courses 1 and 6
151CompletedA Study of Viracept in AIDS Patients With Cytomegalovirus Retinitis
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Nelfinavir mesylate
Sponsor:Agouron Pharmaceuticals
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase II
Number Enrolled:
Funded By:Industry
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Primary Purpose: Treatment
NCT ID:NCT00002169
Other IDs:259A,   Study 517,   AG1343-517
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:May 1999
Acronym:
Primary Completion Date:
Outcome Measure:
152RecruitingGene Therapy and Radioactive Iodine in Treating Patients With Locally Recurrent Prostate Cancer That Did Not Respond to External-Beam Radiation Therapy
Condition:Prostate Cancer
Interventions:Biological: Ad5-CMV-NIS;   Drug: liothyronine sodium;   Genetic: reverse transcriptase-polymerase chain reaction;   Other: laboratory biomarker analysis;   Radiation: iodine I 131
Sponsors:Mayo Clinic;   National Cancer Institute (NCI)
Gender:Male
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:24
Funded By:Other / NIH
Study Type:Interventional
Study Design:Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00788307
Other IDs:CDR0000618542,   P30CA015083,   MC0252,   06-009392,   NCI-2009-01195
First Received Date:November 7, 2008
Start Date:July 2009
Completion Date:
Last Updated Date:January 20, 2011
Last Verified Date:January 2011
Acronym:
Primary Completion Date:November 2011
Outcome Measures:Number of toxicity incidents by NCI CTCAE v3.0 criteria;   Time to PSA progression;   Survival;   Incidence and duration of PSA response;   Duration of PSA control
153CompletedVaccine Therapy in Treating Patients With Advanced or Metastatic Cancer
Conditions:Breast Cancer;   Colorectal Cancer;   Gallbladder Cancer;   Gastric Cancer;   Head and Neck Cancer;   Liver Cancer;   Ovarian Cancer;   Pancreatic Cancer;   Testicular Germ Cell Tumor
Interventions:Biological: CMV pp65 peptide;   Biological: autologous dendritic cells/CMV pp65 peptide mixture;   Biological: recombinant fowlpox-CEA(6D)/TRICOM vaccine;   Biological: tetanus toxoid;   Biological: therapeutic autologous dendritic cells
Sponsors:Duke University;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:
Funded By:Other / NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00027534
Other IDs:CDR0000069041,   DUMC-2840-02-6R1,   NCI-1864
First Received Date:December 7, 2001
Start Date:January 2002
Completion Date:
Last Updated Date:June 12, 2010
Last Verified Date:September 2005
Acronym:
Primary Completion Date:
Outcome Measure:
154Active, not recruitingThymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant
Conditions:Acute Myeloblastic Leukemia;   Lymphoblastic Leukemia;   Myelodysplasia;   Chronic Myeloid Leukemia;   Myelofibrosis;   Lympho-proliferative Diseases
Interventions:Drug: Alentuzumab;   Drug: Globulina antilinfocitaria
Sponsor:Gruppo Italiano Trapianto di Midollo Osseo
Gender:Both
Group:Adult
Phases:Phase II / Phase III
Number Enrolled:100
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00354120
Other IDs:EudraCT:2005-000805-68
First Received Date:July 19, 2006
Start Date:March 2005
Completion Date:
Last Updated Date:October 30, 2009
Last Verified Date:October 2009
Acronym:GLOBAL
Primary Completion Date:November 2008
Outcome Measures:Overall Survival;   Event Free Survival and Disease Free Survival;   Safety:;   Major infective complications (CMV and EBV related PTLD);   Acute and chronic GvHD;   Haematological and immunologic reconstitution;   Incidence of CMV and EBV reactivation;   Other infective complications;   Other toxicities;   Need for DLI
155RecruitingEffect of Burn Size on Cytomegalovirus Reactivation and Correlates of T Cell Immune Function in Burned Patients
Conditions:Burns;   Cytomegalovirus
Intervention:
Sponsor:University of North Carolina, Chapel Hill
Gender:Both
Age Groups:Adult / Senior
Phase:
Number Enrolled:50
Funded By:Other
Study Type:Observational
Study Design:Observational Model: Cohort;   Time Perspective: Prospective
NCT ID:NCT00467532
Other IDs:CMV Reactivation in Burns
First Received Date:April 26, 2007
Start Date:March 2007
Completion Date:December 2011
Last Updated Date:September 27, 2010
Last Verified Date:September 2010
Acronym:
Primary Completion Date:
Outcome Measure:
156CompletedValganciclovir for Treatment of Cytomegalovirus Infection in Solid Organ Transplant Patients
Condition:Cytomegalovirus Infection
Intervention:Drug: Single arm (ganciclovir and valganciclovir)
Sponsors:Hospital Universitari de Bellvitge;   Hoffmann-La Roche
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:21
Funded By:Other / Industry
Study Type:Interventional
Study Design:Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00730769
Other IDs:VALGAN-03
First Received Date:August 5, 2008
Start Date:March 2004
Completion Date:July 2008
Last Updated Date:December 1, 2008
Last Verified Date:November 2008
Acronym:
Primary Completion Date:July 2007
Outcome Measures:Dissapeareance of CMV (pp65) antigenemia, determined in peripheral blood mononuclear cells (PBMC).;   Dissapareance of Cytomegalovirus viremia measured by PCR, determined in plasma samples.;   Area under the curve (AUC) of Ganciclovir after ganciclovir i.v. and valganciclovir oral in steady state.
157TerminatedGanciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy
Conditions:Acute Renal Failure;   Cytomegalovirus Infections;   Multi Organ Failure
Intervention:Drug: intravenous (IV) ganciclovir
Sponsor:University of Oslo School of Pharmacy
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:6
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00264368
Other IDs:GCV-PRISMA
First Received Date:December 9, 2005
Start Date:December 2005
Completion Date:June 2007
Last Updated Date:June 27, 2007
Last Verified Date:June 2007
Acronym:
Primary Completion Date:
Outcome Measures:comparing the total clearance with the RRT derived clearance of GCV;   comparing the volume of distribution with historic controls of non Intensive Care Unit (ICU) patients;   comparing GCV plasma concentration and population model derived estimates of these concentrations when including different relevant clinical co-factors such as: weight, S-creatinine, CL-creatinine, hydration, albumin, rest function of native kidneys etc.;   determine RRT derived GCV clearance during the different filtration/dialysis settings of the RRT machine
158RecruitingMulti-Virus-Specific Cytotoxic T Lymphocytes (CTLs)
Condition:Acute Lymphoblastic Leukemia
Intervention:Biological: Genetically modified T cells
Sponsors:Baylor College of Medicine;   Texas Children's Hospital;   The Methodist Hospital System;   Center for Cell and Gene Therapy, Baylor College of Medicine
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:18
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00840853
Other IDs:23637-MULTIPRAT
First Received Date:February 9, 2009
Start Date:April 2009
Completion Date:April 2029
Last Updated Date:March 4, 2011
Last Verified Date:March 2011
Acronym:MULTIPRAT
Primary Completion Date:April 2014
Outcome Measures:Evaluate safety/persistence of escalating doses of allogeneic CMV, EBV and Adenovirus specific CTLs modified to express artificial T-cell receptors targeting CD19 molecule given for prophylaxis, persistence or relapse of high risk B-cell ALL post HSCT;   To evaluate the effects of gene modified CTL on measurable disease.;   To evaluate the impact of the gene modified CTL on virus-specific T-lymphocyte immune reconstitution.;   To evaluate the impact of the gene modified CTL on normal CD19+ B-cell immune reconstitution post-HSCT.
159Unknown A Study of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Cidofovir
Sponsors:Gilead Sciences;   Anderson Clinical Research
Gender:Both
Age Groups:Child / Adult / Senior
Phase:
Number Enrolled:
Funded By:Industry
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00002384
Other IDs:276A,   GS-95-120,   96ACR-GIL1
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:August 1997
Acronym:
Primary Completion Date:
Outcome Measure:
160CompletedStudies of the Ocular Complications of AIDS (SOCA)--HPMPC Peripheral CMV Retinitis Trial (HPCRT)
Conditions:HIV Infections;   Cytomegalovirus Retinitis
Intervention:Drug: Cidofovir
Sponsor:National Eye Institute (NEI)
Gender:Both
Age Groups:Child / Adult / Senior
Phases:Phase II / Phase III
Number Enrolled:
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Primary Purpose: Treatment
NCT ID:NCT00000142
Other IDs:NEI-41
First Received Date:September 23, 1999
Start Date:April 1994
Completion Date:February 1996
Last Updated Date:September 16, 2009
Last Verified Date:September 2009
Acronym:
Primary Completion Date:
Outcome Measure:

RankStatusStudy
161CompletedThe Safety and Effectiveness of Adefovir Dipivoxil in the Treatment of HIV-Infected Patients
Conditions:Cytomegalovirus Infections;   HIV Infections
Interventions:Drug: Levocarnitine;   Drug: Adefovir dipivoxil;   Drug: Adefovir dipivoxil placebo
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:505
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
NCT ID:NCT00001082
Other IDs:CPCRA 039
First Received Date:November 2, 1999
Start Date:December 1996
Completion Date:August 1999
Last Updated Date:August 6, 2009
Last Verified Date:August 2009
Acronym:
Primary Completion Date:January 1999
Outcome Measure:Morbidity
162CompletedA Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients
Conditions:Cytomegalovirus Infections;   HIV Infections
Interventions:Drug: Valacyclovir hydrochloride;   Drug: Acyclovir
Sponsors:National Institute of Allergy and Infectious Diseases (NIAID);   Glaxo Wellcome
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:1200
Funded By:NIH / Industry
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00001038
Other IDs:ACTG 204,   FDA 104C
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:February 28, 2011
Last Verified Date:February 2011
Acronym:
Primary Completion Date:May 1996
Outcome Measure:
163CompletedThe Safety and Effectiveness of Ganciclovir Plus Interferon Beta in Preventing the Return of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Interventions:Drug: Interferon beta-1b;   Drug: Ganciclovir
Sponsor:Hoffmann-La Roche
Gender:Both
Group:Adult
Phase:
Number Enrolled:
Funded By:Industry
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00002299
Other IDs:017A,   ICM 1285
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:April 1990
Acronym:
Primary Completion Date:
Outcome Measure:
164TerminatedLung Allograft Rejection Gene Expression Observational (LARGO) Study
Conditions:Graft Rejection;   Lung Disease
Intervention:Other: Non-interventional
Sponsor:XDx
Gender:Both
Age Groups:Child / Adult / Senior
Phase:
Number Enrolled:2044
Funded By:Industry
Study Type:Observational
Study Design:Observational Model: Cohort;   Time Perspective: Prospective
NCT ID:NCT00751309
Other IDs:LARGO
First Received Date:September 10, 2008
Start Date:April 2004
Completion Date:January 2009
Last Updated Date:December 17, 2008
Last Verified Date:December 2008
Acronym:LARGO
Primary Completion Date:January 2009
Outcome Measures:Rejection episodes of at least moderate histologic grade which resulted in treatment of the patient with additional corticosteroids, anti-T cell antibodies, or total lymphoid irradiation.;   Obliterative Bronchiolitis diagnosed pathologically by biopsy or by a progressive decline in pulmonary function tests consistent with a diagnosis of Bronchiolitis Obliterans Syndrome (BOS).;   Allograft function as determined via pulmonary function tests.;   The absence of histologic rejection and normal or unchanged allograft function.;   Documented CMV infection by culture, histology, or PCR, and at least one clinical sign or symptom of infection.;   Infections other than CMV, e.g. bacterial, other viral, and fungal infections.;   Rejection of mild to moderate histologic severity prompting augmentation of the patient's chronic immunosuppressive regimen.;   Allograft dysfunction during the study period.;   Rejection of mild to moderate severity with allograft dysfunction prompting plasmapheresis or a diagnosis of "humoral" rejection.;   Lymphoproliferative disorder (aka post-transplant lymphoma).;   Graft Failure or Retransplantation.;   All cause mortality.
165CompletedSuppression of Cytomegalovirus Retinitis Utilizing High Dose Intravenous Acyclovir and Oral Zidovudine in Patients With AIDS
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Interventions:Drug: Zidovudine;   Drug: Acyclovir
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:
Number Enrolled:25
Funded By:NIH
Study Type:Interventional
Study Design:Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00000693
Other IDs:ACTG 070
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:March 11, 2011
Last Verified Date:August 1991
Acronym:
Primary Completion Date:March 1992
Outcome Measure:
166CompletedUsing the Drug Thalidomide to Stimulate T Cells in HIV-Infected People
Condition:HIV Infections
Interventions:Drug: Thalidomide;   Drug: Thalidomide placebo
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:40
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
NCT ID:NCT00053430
Other IDs:1R01AI47742-01A1,   7R01AI047742-02
First Received Date:January 29, 2003
Start Date:April 2001
Completion Date:February 2006
Last Updated Date:August 6, 2009
Last Verified Date:August 2009
Acronym:
Primary Completion Date:August 2005
Outcome Measures:Doubling in HIV Pol-specific CD8 cells, measured by ELISPOT;   Increase in CMV pp65 CD8 cells, measured by ELISPOT in the thalidomide treatment group;   Increase in HIV p24-specific IFN-gamma-secreting CD4 cells in the thalidomide treatment group, measured by fluorescence-activated cell sorting (FACS);   Increase in cytomegalovirus (CMV)-specific interferon (IFN)-gamma-secreting CD4 T cells in the thalidomide treatment group, measured by FACS;   Increase in the frequency of keyhole limpet hemocyanin (KLH)-specific lymphocyte proliferative responses in the thalidomide treatment group;   Increase in adverse events in the thalidomide treatment group
167CompletedValganciclovir to Prevent Cytomegalovirus Infection in Kidney and Kidney/Pancreas Transplant Recipients
Condition:Kidney Trasplant
Intervention:Drug: Valganciclovir
Sponsor:National Institutes of Health Clinical Center (CC)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:12
Funded By:NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00034385
Other IDs:020168,   02-CC-0168
First Received Date:June 19, 2006
Start Date:April 2002
Completion Date:October 2009
Last Updated Date:May 12, 2010
Last Verified Date:August 2008
Acronym:
Primary Completion Date:January 2007
Outcome Measure:
168Unknown Longitudinal Study of Ocular Complications of AIDS (LSOCA)
Conditions:HIV Infections;   Acquired Immunodeficiency Syndrome;   Cytomegalovirus Retinitis
Intervention:Drug: Highly Active Anti-Retroviral Therapy (HAART)
Sponsor:National Eye Institute (NEI)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:
Number Enrolled:
Funded By:NIH
Study Type:Observational
Study Design:Observational Model: Natural History;   Time Perspective: Longitudinal;   Time Perspective: Prospective
NCT ID:NCT00000168
Other IDs:NEI-71
First Received Date:September 23, 1999
Start Date:August 1999
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:October 1999
Acronym:
Primary Completion Date:
Outcome Measure:
169CompletedA Comparison of HIV-Infected Patients With and Without Opportunistic (AIDS-Related) Infection
Conditions:Cytomegalovirus Infections;   Cytomegalovirus Retinitis;   Pneumonia, Pneumocystis Carinii;   HIV Infections
Intervention:
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:
Number Enrolled:90
Funded By:NIH
Study Type:Observational
Study Design:
NCT ID:NCT00005572
Other IDs:ACTG A5067,   AACTG A5067
First Received Date:April 28, 2000
Start Date:
Completion Date:
Last Updated Date:July 31, 2008
Last Verified Date:June 2003
Acronym:
Primary Completion Date:
Outcome Measure:
170RecruitingRandomized Placebo-controlled Trial Evaluating the Safety and Efficacy of Silymarin Treatment in Patients With Acute Viral Hepatitis
Conditions:Acute Hepatitis A;   Acute Hepatitis B;   Acute Hepatitis C;   Acute Hepatitis E;   Acute EBV Hepatitis;   Acute CMV Hepatitis
Interventions:Dietary Supplement: Silymarin;   Other: Lactose monohydrate
Sponsors:University of Maryland;   MADAUS GmbH;   The Egyptian Company for Blood Transfusion Services (EgyBlood);   Tanta Fever Hospital;   Banha Fever Hospital;   Alexandria University
Gender:Both
Age Groups:Adult / Senior
Phases:Phase II / Phase III
Number Enrolled:213
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
NCT ID:NCT00755950
Other IDs:HP-00042363,   LE13K0.48
First Received Date:September 17, 2008
Start Date:October 2008
Completion Date:October 2010
Last Updated Date:February 5, 2010
Last Verified Date:January 2010
Acronym:
Primary Completion Date:August 2010
Outcome Measures:Incidence, severity and duration of Adverse Events;   Normalization of total (<1.0 mg/dl) and direct bilirubin (<0.3 mg/dl);   Normalization of ALT, AST, CRP and ESR;   Symptom resolution & return to normal physical activity;   In AVH patients with specific etiologies resolution of clinical signs and symptoms;   Persistence of acute HCV with progression to chronicity
171CompletedCytomegalovirus Vaccine in Healthy Participants
Condition:Precancerous/Nonmalignant Condition
Intervention:Biological: CMVpp65-A*0201 peptide vaccine
Sponsors:City of Hope Medical Center;   National Cancer Institute (NCI)
Gender:Both
Group:Adult
Phase:Phase I
Number Enrolled:46
Funded By:Other / NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Masking: Double-Blind;   Primary Purpose: Treatment
NCT ID:NCT00712634
Other IDs:CDR0000599675,   P01CA030206,   CHNMC-97092
First Received Date:July 9, 2008
Start Date:November 1997
Completion Date:April 2009
Last Updated Date:December 18, 2009
Last Verified Date:December 2009
Acronym:
Primary Completion Date:April 2009
Outcome Measures:Safety and toxicity;   Immunologic response;   Duration of immunologic response
172Unknown Prophylactic Therapy for Cytomegalovirus in Liver Transplant Recipients
Condition:Liver Transplantation
Intervention:Drug: oral Valganciclovir vs oral Ganciclovir
Sponsor:Oregon Health and Science University
Gender:Both
Age Groups:Adult / Senior
Phase:Phase IV
Number Enrolled:200
Funded By:Other
Study Type:Observational
Study Design:Observational Model: Defined Population;   Observational Model: Natural History;   Time Perspective: Cross-Sectional;   Time Perspective: Retrospective/Prospective
NCT ID:NCT00364052
Other IDs:VAL109
First Received Date:August 11, 2006
Start Date:August 2006
Completion Date:January 2007
Last Updated Date:August 16, 2006
Last Verified Date:August 2006
Acronym:
Primary Completion Date:
Outcome Measure:
173CompletedA Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Ganciclovir
Sponsors:National Institute of Allergy and Infectious Diseases (NIAID);   Hoffmann-La Roche
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:180
Funded By:NIH / Industry
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00000688
Other IDs:ACTG 071,   RS-21592,   ICM 1697
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:March 11, 2011
Last Verified Date:October 1990
Acronym:
Primary Completion Date:February 1995
Outcome Measure:
174CompletedStudies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)
Conditions:HIV Infections;   Acquired Immunodeficiency Syndrome;   Cytomegalovirus Retinitis
Interventions:Drug: Ganciclovir;   Drug: Foscarnet
Sponsor:National Eye Institute (NEI)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Primary Purpose: Treatment
NCT ID:NCT00000134
Other IDs:NEI-33
First Received Date:September 23, 1999
Start Date:December 1992
Completion Date:March 1995
Last Updated Date:September 16, 2009
Last Verified Date:September 2009
Acronym:
Primary Completion Date:
Outcome Measure:
175CompletedVaccine Therapy in Treating Patients With Refractory Stage IV Cancer
Condition:Unspecified Adult Solid Tumor, Protocol Specific
Interventions:Biological: CMV pp65 peptide;   Biological: carcinoembryonic antigen peptide 1-6D;   Biological: therapeutic autologous dendritic cells
Sponsors:Duke University;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:12
Funded By:Other / NIH
Study Type:Interventional
Study Design:Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00057915
Other IDs:CDR0000285629,   DUMC-4180-03-10R1,   NCI-5910
First Received Date:April 7, 2003
Start Date:September 2003
Completion Date:
Last Updated Date:February 6, 2009
Last Verified Date:September 2006
Acronym:
Primary Completion Date:
Outcome Measure:
176CompletedA Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Ganciclovir
Sponsors:National Institute of Allergy and Infectious Diseases (NIAID);   Hoffmann-La Roche
Gender:Both
Age Groups:Child / Adult
Phase:Phase I
Number Enrolled:48
Funded By:NIH / Industry
Study Type:Interventional
Study Design:Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00000668
Other IDs:ACTG 127,   ICM 1505,   FDA 37A,   RS-21592
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:August 25, 2008
Last Verified Date:March 1991
Acronym:
Primary Completion Date:
Outcome Measure:
177CompletedImmunosuppressive Effects of Mycophenolate Mofetil and Valganciclovir in Kidney Transplant Recipients
Condition:Renal Failure
Intervention:Procedure: phlebotomy
Sponsors:Indiana University School of Medicine;   Hoffmann-La Roche
Gender:Both
Age Groups:Adult / Senior
Phase:
Number Enrolled:50
Funded By:Other / Industry
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
NCT ID:NCT00198224
Other IDs:0212-78,   VAL074
First Received Date:September 13, 2005
Start Date:January 2003
Completion Date:May 2005
Last Updated Date:September 13, 2005
Last Verified Date:November 2004
Acronym:
Primary Completion Date:
Outcome Measures:The primary endpoint of this study is the analysis of immune responsiveness in vitro in patients before and after routine cessation of VGCV.;   Secondary endpoints of this study are the analysis of absolute neutrophil count before and after routine cessation of VGCV. This will be obtained from the patient’s complete blood count and differential.
178Not yet recruitingSERCA Gene Therapy Trial
Conditions:Advanced Heart Failure;   Patients That Have Received a Left Ventricular Assist Device
Interventions:Genetic: AAV6.SERCA2a;   Procedure: Placebo
Sponsors:Imperial College London;   Leducq Foundation
Gender:Both
Age Groups:Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:16
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
NCT ID:NCT00534703
Other IDs:SERCA1,   EudraCT Number: 2007-002809-48
First Received Date:September 24, 2007
Start Date:January 2010
Completion Date:December 2012
Last Updated Date:August 3, 2009
Last Verified Date:August 2009
Acronym:
Primary Completion Date:December 2012
Outcome Measures:Level and extent of gene expression measured by PCR of SERCA;   Levels of SERCA protein;   Viral DNA and RNA;   Other relevant proteins e.g. phospholamban, the sarcoplasmic reticulum calcium release channel, the Na+/Ca2+-exchanger.;   Function of isolated myocytes (depending on availability of cardiac tissue);   Left ventricular function assessed by echocardiography;   Incidence of major adverse cardiovascular events (MACE) at 30 days
179CompletedMelphalan 200 mg/m2 Versus Melphalan 100 mg/m2 in Newly Diagnosed Myeloma Patients
Conditions:Multiple Myeloma;   Diagnosis
Intervention:Procedure: Autologous transplantation
Sponsor:Azienda Ospedaliera San Giovanni Battista
Gender:Both
Group:Adult
Phase:Phase III
Number Enrolled:298
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00950768
Other IDs:GISMM2001
First Received Date:July 31, 2009
Start Date:February 2002
Completion Date:June 2009
Last Updated Date:July 31, 2009
Last Verified Date:July 2009
Acronym:
Primary Completion Date:May 2009
Outcome Measures:Primary endpoints of the study were Overall Survival defined as the time from diagnosis until death from any cause; Progression Free Survival defined as the time from diagnosis until death from any cause or date of first relapse or progression.;   Secondary endpoint was time to progression (TTP) defined as the time from the date of diagnosis to relapse or death from progression.
180CompletedGene Therapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
Condition:Lung Cancer
Interventions:Biological: Ad5CMV-p53 gene;   Radiation: radiation therapy
Sponsors:Eastern Cooperative Oncology Group;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:
Funded By:Other / NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00004225
Other IDs:CDR0000067466,   ECOG-8597
First Received Date:January 28, 2000
Start Date:January 2000
Completion Date:
Last Updated Date:July 3, 2010
Last Verified Date:April 2004
Acronym:
Primary Completion Date:
Outcome Measure

RankStatusStudy
181CompletedGene Therapy Plus Chemotherapy in Treating Patients With Breast Cancer
Condition:Breast Cancer
Interventions:Biological: Ad5CMV-p53 gene;   Drug: chemotherapy
Sponsors:Fox Chase Cancer Center;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:
Funded By:Other / NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00004038
Other IDs:CDR0000066480,   FCCC-97009,   NCI-T97-0042
First Received Date:December 10, 1999
Start Date:January 1999
Completion Date:
Last Updated Date:February 6, 2009
Last Verified Date:June 2001
Acronym:
Primary Completion Date:
Outcome Measure:
182CompletedGene Therapy in Treating Patients With Recurrent Malignant Gliomas
Condition:Brain and Central Nervous System Tumors
Interventions:Biological: Ad5CMV-p53 gene;   Procedure: conventional surgery
Sponsors:North American Brain Tumor Consortium;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:
Funded By:Other / NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00004041
Other IDs:CDR0000066871,   NABTC-9703
First Received Date:December 10, 1999
Start Date:March 1999
Completion Date:
Last Updated Date:February 6, 2009
Last Verified Date:December 2002
Acronym:
Primary Completion Date:
Outcome Measure:
183Unknown Gene Therapy in Treating Patients With Cancer of The Liver
Condition:Liver Cancer
Intervention:Biological: Ad5CMV-p53 gene
Sponsors:University of Pittsburgh;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:30
Funded By:Other / NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00003147
Other IDs:CDR0000065932,   PCI-96-035,   NCI-T96-0059
First Received Date:April 6, 2000
Start Date:February 1998
Completion Date:
Last Updated Date:July 29, 2009
Last Verified Date:May 2000
Acronym:
Primary Completion Date:
Outcome Measure:
184CompletedGene Therapy in Treating Patients With Non-Small Cell Lung Cancer That Cannot Be Surgically Removed
Condition:Lung Cancer
Intervention:Biological: Ad5CMV-p53 gene
Sponsors:Eastern Cooperative Oncology Group;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:
Funded By:Other / NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00003649
Other IDs:CDR0000066741,   E-6597
First Received Date:November 1, 1999
Start Date:November 1998
Completion Date:
Last Updated Date:February 6, 2009
Last Verified Date:February 2002
Acronym:
Primary Completion Date:
Outcome Measure:
185Unknown Gene Therapy in Treating Patients With Advanced Recurrent or Persistent Ovarian Cancer or Primary Peritoneal Cancer
Conditions:Ovarian Cancer;   Peritoneal Cavity Cancer
Intervention:Biological: Ad5CMV-p53 gene
Sponsors:Simmons Cancer Center;   National Cancer Institute (NCI)
Gender:Female
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:20
Funded By:Other / NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00003450
Other IDs:CDR0000066481,   UTSMC-089733300,   NCI-T97-0096
First Received Date:November 1, 1999
Start Date:September 1998
Completion Date:
Last Updated Date:February 6, 2009
Last Verified Date:June 2002
Acronym:
Primary Completion Date:
Outcome Measure:
186Unknown Gene Therapy in Treating Patients With Recurrent Head and Neck Cancer
Condition:Head and Neck Cancer
Intervention:Biological: Ad5CMV-p53 gene
Sponsor:Aventis Pharmaceuticals
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:39
Funded By:Industry
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00003257
Other IDs:CDR0000066148,   AVENTIS-T-202,   MCC-11653,   RP-T-202,   NCI-V98-1394
First Received Date:November 1, 1999
Start Date:January 1998
Completion Date:
Last Updated Date:February 6, 2009
Last Verified Date:April 2000
Acronym:
Primary Completion Date:
Outcome Measure:
187CompletedGene Therapy in Treating Patients With Advanced Bladder Cancer
Condition:Bladder Cancer
Intervention:Biological: Ad5CMV-p53 gene
Sponsors:M.D. Anderson Cancer Center;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:
Funded By:Other / NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00003167
Other IDs:CDR0000065968,   MDA-DM-96172,   NCI-T96-0073
First Received Date:November 1, 1999
Start Date:May 1998
Completion Date:
Last Updated Date:February 6, 2009
Last Verified Date:December 2002
Acronym:
Primary Completion Date:
Outcome Measure:
188CompletedGene Therapy in Treating Patients With Ovarian Cancer
Condition:Ovarian Cancer
Interventions:Biological: Ad5CMV-p53 gene;   Procedure: laparoscopic surgery
Sponsors:M.D. Anderson Cancer Center;   National Cancer Institute (NCI)
Gender:Female
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:
Funded By:Other / NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00003588
Other IDs:CDR0000066657,   MDA-ID-97228,   NCI-T97-0111
First Received Date:November 1, 1999
Start Date:September 1998
Completion Date:
Last Updated Date:February 6, 2009
Last Verified Date:June 2002
Acronym:
Primary Completion Date:
Outcome Measure:
189CompletedVirus-Specific Cytotoxic T-Lymphocytes (CTLs) for Adenovirus Infection Following an Allogeneic Stem Cell Transplant
Condition:Adenoviridae Infections
Interventions:Genetic: Cytomegalovirus (CMV)-specific Cytotoxic T-Lymphocytes (CTL);   Genetic: Epstein-Barr Virus (EBV)-specific Cytotoxic T-Lymphocytes (CTL)
Sponsors:National Heart, Lung, and Blood Institute (NHLBI);   Baylor College of Medicine;   Texas Children's Hospital
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:18
Funded By:NIH / Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00111033
Other IDs:436,   U54 HL081007-01,   LYPTAIST,   14097
First Received Date:May 16, 2005
Start Date:September 2003
Completion Date:June 2008
Last Updated Date:September 29, 2008
Last Verified Date:September 2008
Acronym:
Primary Completion Date:June 2008
Outcome Measure:Maximum tolerated dose of AdV-CTL (i.e., dose with the probability closest to the target toxicity rate at the following termination points: preinfusion, 24 hours post-infusion [optional], Day 3 or 4 [optional], and 1, 2, 4, 6, and 8 weeks post-infusion)
190Active, not recruitingEmergency Use of Donor Lymphocytes in Treating Patients Who Have Undergone Donor Stem Cell Transplant and Have Cytomegalovirus Infections
Condition:Cancer
Interventions:Biological: cytomegalovirus IE-1-specific cytotoxic T lymphocytes;   Biological: cytomegalovirus pp65-specific cytotoxic T lymphocytes;   Biological: therapeutic allogeneic lymphocytes;   Genetic: polymerase chain reaction;   Other: flow cytometry;   Other: immunological diagnostic method;   Other: laboratory biomarker analysis
Sponsors:Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:20
Funded By:Other / NIH
Study Type:Interventional
Study Design:Masking: Open Label;   Primary Purpose: Supportive Care
NCT ID:NCT00769613
Other IDs:CDR0000615167,   PSCI-PSHCI-08-051
First Received Date:October 8, 2008
Start Date:August 2008
Completion Date:
Last Updated Date:September 18, 2010
Last Verified Date:August 2010
Acronym:
Primary Completion Date:August 2014
Outcome Measures:Safety;   Toxicity;   Time to development of cytomegalovirus (CMV)-specific immune reconstitution;   CMV DNA levels;   Time during post-infusion follow-up at which the dominant CMV pp65- and IE-1 epitopes for the donor is recognized by the cytotoxic T-cell lymphocytes (CTL);   Feasibility of CMV pp65- and IE-1 CTL culture after CMV vaccination of seronegative donors
191CompletedTransfusion-Transmitted Cytomegalovirus Prevention in Neonates
Conditions:Blood Transfusion;   Cytomegalovirus Infections
Intervention:Drug: immunoglobulins
Sponsor:National Heart, Lung, and Blood Institute (NHLBI)
Gender:Both
Group:Child
Phase:Phase III
Number Enrolled:
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Masking: Double-Blind;   Primary Purpose: Prevention
NCT ID:NCT00000584
Other IDs:304
First Received Date:October 27, 1999
Start Date:July 1983
Completion Date:
Last Updated Date:January 3, 2006
Last Verified Date:December 2005
Acronym:
Primary Completion Date:
Outcome Measure:
192CompletedCytomegalovirus Reactivation in Cancer Patients Receiving Chemotherapy
Conditions:Cancer;   Cytomegalovirus
Intervention:
Sponsor:Mackay Memorial Hospital
Gender:Both
Age Groups:Adult / Senior
Phase:
Number Enrolled:20
Funded By:Other
Study Type:Observational
Study Design:Observational Model: Defined Population;   Primary Purpose: Screening;   Time Perspective: Longitudinal;   Time Perspective: Prospective
NCT ID:NCT00366717
Other IDs:MMH-I-S-144
First Received Date:August 18, 2006
Start Date:June 2005
Completion Date:January 2006
Last Updated Date:August 18, 2006
Last Verified Date:January 2006
Acronym:
Primary Completion Date:
Outcome Measure:
193CompletedA Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Ganciclovir
Sponsor:Roche Global Development
Gender:Both
Age Groups:Child / Adult / Senior
Phase:
Number Enrolled:450
Funded By:Other
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Primary Purpose: Treatment
NCT ID:NCT00002134
Other IDs:037B,   GANS2304
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:July 1997
Acronym:
Primary Completion Date:
Outcome Measure:
194CompletedA Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment With Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People With AIDS
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Ganciclovir
Sponsor:Hoffmann-La Roche
Gender:Both
Age Groups:Child / Adult / Senior
Phase:
Number Enrolled:150
Funded By:Industry
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Primary Purpose: Treatment
NCT ID:NCT00002257
Other IDs:059B,   ICM 1653
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:July 1992
Acronym:
Primary Completion Date:
Outcome Measure:
195CompletedA Study of the Safety and Tolerance of Long-Term Therapy With Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons With AIDS
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Interventions:Drug: Zidovudine;   Drug: Ganciclovir
Sponsor:Hoffmann-La Roche
Gender:Both
Age Groups:Child / Adult / Senior
Phase:
Number Enrolled:100
Funded By:Industry
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Primary Purpose: Treatment
NCT ID:NCT00002034
Other IDs:029F,   ICM 1692
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:January 1992
Acronym:
Primary Completion Date:
Outcome Measure:
196CompletedA Randomized Comparative Pharmacokinetic Study of Oral Ganciclovir After Treatment With Intravenous Ganciclovir for Cytomegalovirus Gastrointestinal Disease in AIDS Patients
Conditions:Colitis;   HIV Infections
Interventions:Drug: Glutamic acid hydrochloride;   Drug: Ganciclovir
Sponsors:National Institute of Allergy and Infectious Diseases (NIAID);   Hoffmann-La Roche
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:24
Funded By:NIH / Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Primary Purpose: Treatment
NCT ID:NCT00000768
Other IDs:ACTG 183
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:August 25, 2008
Last Verified Date:August 1998
Acronym:
Primary Completion Date:
Outcome Measure:
197CompletedA Study of Ganciclovir in the Treatment of Cytomegalovirus of the Eyes
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Ganciclovir
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:25
Funded By:NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00001062
Other IDs:ACTG 278
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:August 1, 2008
Last Verified Date:December 1996
Acronym:
Primary Completion Date:
Outcome Measure:
198CompletedA Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People With AIDS Who Have Received Prior Ganciclovir Therapy
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Ganciclovir
Sponsor:Hoffmann-La Roche
Gender:Both
Age Groups:Child / Adult / Senior
Phase:
Number Enrolled:225
Funded By:Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety Study;   Primary Purpose: Treatment
NCT ID:NCT00002247
Other IDs:059C,   ICM 1774
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:March 1993
Acronym:
Primary Completion Date:
Outcome Measure:
199Unknown Kinetics of Response of Cytomegalovirus With Ganciclovir Treatment Using Quantitative Real-Time PCR
Condition:Cytomegalovirus Infections
Intervention:Drug: ganciclovir
Sponsor:National Center for Research Resources (NCRR)
Gender:Both
Age Groups:Adult / Senior
Phase:
Number Enrolled:
Funded By:NIH
Study Type:Interventional
Study Design:Primary Purpose: Diagnostic
NCT ID:NCT00004573
Other IDs:NCRR-M01RR00036-0728,   M01RR00036
First Received Date:February 18, 2000
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:November 2001
Acronym:
Primary Completion Date:
Outcome Measure:
200CompletedCandidate HIV Vaccine
Condition:HIV Infections
Intervention:Drug: VRC-HIVDNA016-00-VP
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Group:Adult
Phase:Phase I
Number Enrolled:15
Funded By:NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00089531
Other IDs:040254,   04-I-0254
First Received Date:August 5, 2004
Start Date:August 2004
Completion Date:January 2008
Last Updated Date:January 16, 2008
Last Verified Date:January 2008
Acronym:
Primary Completion Date:
Outcome Measure:

RankStatusStudy
201Unknown Airway Pressure Release Ventilation (APRV) is Superior to ARDS Net Low Tidal Volume-Cycled Ventilation in ALI/ARDS Patients
Conditions:Acute Lung Injury;   Adult Respiratory Distress Syndrome;   Kidney Injury
Interventions:Device: Volume-Cycled Assist-Control (AC) mode;   Device: Airway Pressure Release Ventilation (APRV) mode
Sponsor:University of Tennessee, Chattanooga
Gender:Both
Age Groups:Adult / Senior
Phase:
Number Enrolled:368
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00793013
Other IDs:123456789
First Received Date:November 17, 2008
Start Date:December 2008
Completion Date:
Last Updated Date:December 8, 2008
Last Verified Date:November 2008
Acronym:
Primary Completion Date:
Outcome Measures:All cause mortality;   Number of ventilator-free days;   Length of ICU stay and /or Total hospital days;   To determine the effects of APRV ventilation versus ARDS net low volume-cycle ventilation on the incidence of of AKI;   To determine the effects of APRV ventilation versus ARDS net low volume-cycle ventilation on the NGAL, KIM-1, and IL-18 urine biomarkers for AKI;   To determine the effects of APRV ventilation versus ARDS net low volume-cycle ventilation in maintaining hourly urine output > 0.5 mls/kg/hr;   Will determine urinary aquaporin-2 levels in patients randomized to APRV ventilation versus ARDS net low volume-cycle ventilation
202CompletedT Lymphocytes and Anti-CD45 Monoclonal Antibody in Treating Patients With Epstein-Barr Virus-Positive Nasopharyngeal Cancer
Condition:Head and Neck Cancer
Interventions:Biological: anti-CD45 monoclonal antibody;   Biological: autologous Epstein-Barr virus-specific cytotoxic T lymphocytes
Sponsor:Baylor College of Medicine
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:18
Funded By:Other
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00608257
Other IDs:CDR0000582383,   BCM-H-14214,   BCM-CLANC
First Received Date:February 1, 2008
Start Date:September 2003
Completion Date:
Last Updated Date:April 18, 2009
Last Verified Date:November 2008
Acronym:
Primary Completion Date:November 2008
Outcome Measures:Maximum tolerated dose of autologous Epstein-Barr virus (EBV)-specific cytotoxic T-lymphocytes (CTL) in combination with anti-CD45 monoclonal antibody;   Safety;   Changes in laboratory data at baseline, 2, 4, 6, and 8 weeks and at 3 months;   Extent and duration of immune depletion at pre-antibody infusion, pre-CTL infusion, 4 hours after infusion on days 3 and 4, and at 1, 2, 4, 6, and 8 weeks post-CTL infusion;   Immunologic function as measured by interferon-gamma, percentage of tetramer-positive cells in peripheral blood, and EBV-DNA in plasma;   Frequency of T-cells specific for CMV antigens (or for adenovirus in CMV-seronegative individuals) and EBV antigens at each time point of follow-up;   Correlation between endogenously reconstituted versus adoptively transferred T-cells;   Overall response rate
203RecruitingCompassionate Use Study of Carfilzomib
Condition:Multiple Myeloma
Intervention:Drug: Carfilzomib
Sponsors:University of Arkansas;   Onyx Therapeutics, Inc.
Gender:Both
Age Groups:Adult / Senior
Phase:
Number Enrolled:30
Funded By:Other / Industry
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00999414
Other IDs:UARK 2009-32
First Received Date:October 20, 2009
Start Date:November 2009
Completion Date:December 2011
Last Updated Date:February 3, 2011
Last Verified Date:February 2011
Acronym:2009-32
Primary Completion Date:November 2011
Outcome Measure:prevent CMV
204Unknown A Pilot Trial With Subcutaneous Alemtuzumab and Oral Fludarabinephosphate for the Determination of Safety, Efficacy and Molecular Profiling for the Prediction of Response
Condition:B-Cell Chronic Lymphocytic Leukemia
Interventions:Drug: Fludarabine phosphate;   Drug: Alemtuzumab
Sponsors:Arbeitsgemeinschaft medikamentoese Tumortherapie;   Schering-Plough
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:28
Funded By:Other / Industry
Study Type:Interventional
Study Design:Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00565981
Other IDs:FLUSALEM
First Received Date:November 29, 2007
Start Date:March 2004
Completion Date:December 2008
Last Updated Date:June 4, 2008
Last Verified Date:June 2008
Acronym:
Primary Completion Date:October 2007
Outcome Measures:Safety and tolerability;   Complete and overall response rate;   Infections grade III, IV;   Rate of CMV reactivation;   Time to retreatment;   Overall survival;   Response in lymphatic compartments;   Molecular response/ immunologic MRD response;   Quality of Life
205Active, not recruitingNonmyeloablative Allogeneic Stem Cell Transplantation From HLA-Matched Unrelated Donor for the Treatment of Hematologic Disorders
Conditions:AML;   ALL;   CLL;   Myelodysplastic Syndrome;   Non-Hodgkin's Lymphoma;   Hodgkin's Lymphoma;   Multiple Myeloma;   Aplastic Anemia;   Myeloproliferative Disorder
Intervention:Drug: Cyclophosphamide; Fludarabine; Cyclosporin; CAMPATH-1H (Alemtuzumab); GM-CSF
Sponsors:Beth Israel Deaconess Medical Center;   Bayer
Gender:Both
Age Groups:Child / Adult
Phase:Phase II
Number Enrolled:25
Funded By:Other / Industry
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00533923
Other IDs:2002P000219
First Received Date:September 20, 2007
Start Date:December 2002
Completion Date:
Last Updated Date:October 16, 2009
Last Verified Date:October 2009
Acronym:
Primary Completion Date:January 2007
Outcome Measures:Primary objective of study is to determine the safety of non-myeloablative allogenic stem cell transplantation from matched unrelated donors in patients with hematologic malignancies with a focus on the incidence of treatment-related mortality.;   Secondary clinical endpoints includes; incidence of graft failure or rejection; incidence and severity of acute and chronic GVHD; tumor response, and long-term overall and disease-free survival.
206TerminatedEfects of Noninvasive Mechanical Ventilation and Conventional Mechanical Ventilation in Patients With Severe Comunity Pneumonia
Conditions:Community Acquired Pneumonia.;   Acute Hypoxemic Respiratory Failure
Intervention:Device: Non invasive mechanical ventilation
Sponsor:Hospital Privado del Sur
Gender:Both
Age Groups:Adult / Senior
Phase:
Number Enrolled:
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label
NCT ID:NCT00523497
Other IDs:NIV67-07
First Received Date:August 30, 2007
Start Date:
Completion Date:
Last Updated Date:August 30, 2007
Last Verified Date:August 2007
Acronym:NIMV AND SCAP
Primary Completion Date:
Outcome Measures:The primary aim of this study was to compare the effects of NIMV on mortality rate and length of stay at the ICU with the effects of CMV;   The secondary aims were to evaluate the incidence and the complications of OTI as well as to compare the improvements in the gas exchange.
207CompletedStudy of Prophylactic Vs Preemptive Valganciclovir
Condition:Cytomegalovirus Infection
Intervention:Drug: Valganciclovir
Sponsors:Washington University School of Medicine;   Hoffmann-La Roche
Gender:Both
Age Groups:Adult / Senior
Phase:
Number Enrolled:120
Funded By:Other / Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT00374686
Other IDs:VAL015 HSC02-0140
First Received Date:September 7, 2006
Start Date:March 2003
Completion Date:September 2005
Last Updated Date:September 7, 2006
Last Verified Date:September 2005
Acronym:
Primary Completion Date:
Outcome Measures:Primary outcomes included occurrence of CMV infection and disease and response to therapy;   Secondary outcomes were incidence of acute rejection, allograft survival, allograft dysfunction, death, and incidence of neutropenia
208Not yet recruitingStudy Comparing Valganciclovir Versus Ganciclovir in Patients Following Allogeneic Stem Cell Transplantation
Condition:Allogeneic Stem Cell Transplantation
Interventions:Drug: Valganciclovir;   Drug: Ganciclovir
Sponsors:Pierrel Research Europe GmbH;   Roche Pharma AG
Gender:Both
Age Groups:Adult / Senior
Phase:Phase III
Number Enrolled:212
Funded By:Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT01185223
Other IDs:ML 22371
First Received Date:August 18, 2010
Start Date:September 2010
Completion Date:
Last Updated Date:August 18, 2010
Last Verified Date:August 2010
Acronym:CONVINCE
Primary Completion Date:December 2012
Outcome Measures:Efficacy and Safety of oral valganciclovir versus intravenous ganciclovir;   Combined secondary endpoint of efficacy and safety
209CompletedGanciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections
Conditions:Cytomegalovirus Infections;   HIV Infections
Intervention:Drug: Ganciclovir
Sponsor:Hoffmann-La Roche
Gender:Both
Age Groups:Adult / Senior
Phase:
Number Enrolled:
Funded By:Industry
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00002024
Other IDs:029B,   ICM 1257A
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:September 1989
Acronym:
Primary Completion Date:
Outcome Measure:
210CompletedA Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Fomivirsen sodium
Sponsor:Isis Pharmaceuticals
Gender:Both
Age Groups:Adult / Senior
Phase:
Number Enrolled:
Funded By:Industry
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
NCT ID:NCT00002187
Other IDs:251D,   ISIS 2922-CS9
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:December 1998
Acronym:
Primary Completion Date:
Outcome Measure:
211CompletedA Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Interventions:Drug: Fomivirsen sodium;   Drug: Ganciclovir
Sponsor:Isis Pharmaceuticals
Gender:Both
Age Groups:Adult / Senior
Phase:Phase II
Number Enrolled:194
Funded By:Industry
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00002156
Other IDs:251B,   ISIS 2922-CS3
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:December 1998
Acronym:
Primary Completion Date:
Outcome Measure:
212CompletedGanciclovir Implant Study for Cytomegalovirus Retinitis
Conditions:HIV Infections;   Acquired Immunodeficiency Syndrome;   Cytomegalovirus Retinitis
Intervention:Device: Sustained-Release Intraocular Drug Delivery System
Sponsor:National Eye Institute (NEI)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase III
Number Enrolled:
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Primary Purpose: Treatment
NCT ID:NCT00000118
Other IDs:NEI-14
First Received Date:September 23, 1999
Start Date:October 1992
Completion Date:December 1993
Last Updated Date:September 16, 2009
Last Verified Date:September 2009
Acronym:
Primary Completion Date:
Outcome Measure:
213CompletedOral Valganciclovir Versus Valacyclovir
Conditions:Chronic Lymphocytic Leukemia;   Leukemia
Interventions:Drug: Valganciclovir;   Drug: Valacyclovir
Sponsors:M.D. Anderson Cancer Center;   Hoffmann-La Roche
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase II
Number Enrolled:46
Funded By:Other / Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00562770
Other IDs:ID02-666
First Received Date:November 20, 2007
Start Date:September 2003
Completion Date:July 2006
Last Updated Date:December 10, 2007
Last Verified Date:December 2007
Acronym:
Primary Completion Date:
Outcome Measures:CBC, platelet and differential. BUN, creatinine, total bilirubin, alkaline phosphatase, LDH, SGPT;   CMV antigenemia
214CompletedDiaphragmatic Function in Ventilated Patients
Condition:Critically Ill
Intervention:
Sponsor:University Hospital, Montpellier
Gender:Both
Age Groups:Adult / Senior
Phase:
Number Enrolled:60
Funded By:Other
Study Type:Observational
Study Design:Observational Model: Case-Only;   Time Perspective: Prospective
NCT ID:NCT00786526
Other IDs:UF7854
First Received Date:November 5, 2008
Start Date:March 2008
Completion Date:July 2010
Last Updated Date:October 28, 2010
Last Verified Date:October 2010
Acronym:
Primary Completion Date:July 2010
Outcome Measure:
215Unknown Prevalence of Cytomegalovirus, Epstein Barr Virus and Human Herpes 6 Virus in Inflammatory Bowel Disease
Conditions:Crohn's Disease;   Ulcerative Colitis
Intervention:
Sponsors:University of Miami;   Hoffmann-La Roche
Gender:Both
Age Groups:Adult / Senior
Phase:
Number Enrolled:180
Funded By:Other / Industry
Study Type:Observational
Study Design:Observational Model: Defined Population;   Observational Model: Natural History;   Time Perspective: Cross-Sectional;   Time Perspective: Prospective
NCT ID:NCT00222378
Other IDs:WIRB® Protocol #20050561,   Protocol VAL094
First Received Date:September 19, 2005
Start Date:April 2005
Completion Date:April 2005
Last Updated Date:September 19, 2005
Last Verified Date:April 2005
Acronym:
Primary Completion Date:
Outcome Measure:
216CompletedAn Open-Label Study of the Safety and Efficacy of Cidofovir for the Treatment of Relapsing Cytomegalovirus Retinitis in Patients With AIDS
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Interventions:Drug: Cidofovir;   Drug: Probenecid
Sponsor:Gilead Sciences
Gender:Both
Age Groups:Child / Adult / Senior
Phase:
Number Enrolled:100
Funded By:Industry
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00002142
Other IDs:216B,   GS-93-107
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:October 1995
Acronym:
Primary Completion Date:
Outcome Measure:
217CompletedViral Activation Transfusion Study (VATS)
Conditions:Acquired Immunodeficiency Syndrome;   Blood Transfusion;   Cytomegalovirus Infections;   HIV Infections
Intervention:Procedure: blood transfusion
Sponsor:National Heart, Lung, and Blood Institute (NHLBI)
Gender:Both
Age Groups:Adult / Senior
Phase:
Number Enrolled:
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Primary Purpose: Prevention
NCT ID:NCT00000593
Other IDs:313
First Received Date:October 27, 1999
Start Date:November 1994
Completion Date:March 2001
Last Updated Date:January 3, 2006
Last Verified Date:December 2005
Acronym:
Primary Completion Date:
Outcome Measure:
218RecruitingAssessing HIV-Related Oral Mucosal Disease and Using Saliva to Measure Viral Load
Condition:HIV Infections