2 фаза клинические исследования у детей при цитомегаловирусной инфекции


RankStatusStudy
1CompletedCytomegalovirus (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
2Active, 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.
3RecruitingAlternate 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
4Unknown 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.
5TerminatedA 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.
6Active, 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.
7RecruitingStudy 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
8CompletedPhase 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:
9RecruitingCytotoxic 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.
10CompletedCytomegalovirus 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
11RecruitingInjection 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
12RecruitingT-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
13CompletedValganciclovir 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.
14CompletedTAMOVALCIR 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.
15CompletedA 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:
16TerminatedA 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:
17RecruitingSafety 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
18CompletedThe 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:
19CompletedA 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:
20CompletedThe 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:
RankStatusStudy
21CompletedThe 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:
22CompletedStudies 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:
23CompletedComparison 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:
24CompletedA 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:
25CompletedStudies 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:
26Active, 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.
27CompletedOral 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
28CompletedA Study of Valcyte (Valganciclovir) Syrup Formulation in Pediatric Solid Organ Transplant Recipients
Condition:Cytomegalovirus Infections
Intervention:Drug: valganciclovir [Valcyte]
Sponsor:Hoffmann-La Roche
Gender:Both
Group:Child
Phase:Phase II
Number Enrolled:63
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: Treatment
NCT ID:NCT00090766
Other IDs:WV16726
First Received Date:September 3, 2004
Start Date:
Completion Date:March 2006
Last Updated Date:May 13, 2009
Last Verified Date:May 2009
Acronym:
Primary Completion Date:
Outcome Measures:Adverse events, opportunistic infections, dose reductions, interruptions, or discontinuations because of adverse events, adverse changes in hematology and serum chemistry values;   Pharmacokinetic parameters; incidence of CMV viremia and disease
29Active, not recruitingSirolimus & Mycophenolate Mofetil as GVHD Prophylaxis in Myeloablative, Matched Related Donor HCT
Condition:Hematologic Diseases
Interventions:Drug: Sirolimus;   Drug: Mycophenolate Mofetil;   Drug: Carmustine;   Drug: VP-16;   Drug: cyclophosphamide
Sponsors:Stanford University;   National Institutes of Health (NIH)
Gender:Both
Age Groups:Child / Adult
Phase:Phase II
Number Enrolled:38
Funded By:Other / 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:NCT01220297
Other IDs:SU-09092009-3841,   BMT209
First Received Date:November 24, 2009
Start Date:September 2009
Completion Date:October 2012
Last Updated Date:February 17, 2011
Last Verified Date:February 2011
Acronym:
Primary Completion Date:October 2012
Outcome Measures:Incidence of grade II-IV acute GVHD at D+100 post-transplant;   Grade III-IV acute GVHD;   Pharmacokinetics of MMF;   Veno-occlusive Disease Incidence of Infection CMV reactivation;   Chronic GVHD Disease-free and Overall Survival;   Time to neutrophil and platelet engraftment Thrombotic microangiopathy Severity of Mucositis
30Unknown Safety of a Multitherapy Regimen Containing Alemtuzumab in Children and Adolescents After Kidney Transplantation
Conditions:Kidney Failure, Chronic;   Kidney Transplantation;   Immunosuppression
Interventions:Drug: Alemtuzumab;   Drug: Tacrolimus;   Drug: Mycophenolate mofetil;   Drug: Sirolimus
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult
Phase:Phase II
Number Enrolled:35
Funded By:NIH
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:NCT00240994
Other IDs:DAIT PC01
First Received Date:October 14, 2005
Start Date:January 2005
Completion Date:
Last Updated Date:March 26, 2009
Last Verified Date:April 2007
Acronym:
Primary Completion Date:November 2009
Outcome Measures:Proportion of participants who have graft loss or death;   Longer term patient and graft survival;   Occurrence, severity, and treatment for acute and humoral rejection;   Incidence of chronic allograft nephropathy;   Change in serum creatinine;   kidney function;   Incidence and severity of hyperlipidemia, hypertension, anemia, leukopenia, neutropenia, and the requirement for treatment;   Infectious complications, including bacterial, viral, and fungal infections;   Surgical complications;   Incidence and duration of re-hospitalizations after transplantation;   Incidence of biopsy proven post-transplant lymphoproliferative disorder (PTLD);   Incidence of opportunistic infections, especially cytomegalovirus (CMV) and Epstein-Barr virus (EBV) viremia;   Treatment for viremia and disease;   Incidence of delayed graft function
31CompletedA Multicenter, Double Blind, Comparative Study of Zidovudine Alone Versus Zidovudine and Acyclovir as Treatment for HIV-Infected Patients With CD4+ Counts Less Than 200 Cells/mm3
Condition:HIV Infections
Interventions:Drug: Zidovudine;   Drug: Acyclovir
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase II
Number Enrolled:400
Funded By:NIH
Study Type:Interventional
Study Design:Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
NCT ID:NCT00000712
Other IDs:ACTG 063
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:November 1994
Outcome Measure:
32Unknown Alemtuzumab, Fludarabine, and Busulfan Followed By Donor Stem Cell Transplant in Treating Young Patients With Hematologic Disorders
Conditions:Congenital Amegakaryocytic Thrombocytopenia;   Diamond-Blackfan Anemia;   Leukemia;   Myelodysplastic Syndromes;   Severe Congenital Neutropenia
Interventions:Biological: alemtuzumab;   Drug: busulfan;   Drug: cyclosporine;   Drug: fludarabine phosphate;   Drug: methotrexate;   Drug: methylprednisolone;   Procedure: allogeneic bone marrow transplantation;   Procedure: allogeneic hematopoietic stem cell transplantation;   Procedure: peripheral blood stem cell transplantation;   Procedure: umbilical cord blood transplantation
Sponsors:University of California, San Francisco;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Child / Adult
Phase:Phase II
Number Enrolled:35
Funded By:Other / NIH
Study Type:Interventional
Study Design:Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00301834
Other IDs:CDR0000462406,   UCSF-04152,   UCSF-00452,   UCSF-H411-25738-02
First Received Date:March 9, 2006
Start Date:January 2005
Completion Date:
Last Updated Date:July 3, 2010
Last Verified Date:December 2008
Acronym:
Primary Completion Date:December 2010
Outcome Measures:Engraftment at 6 weeks post transplantation;   Treatment-related mortality at 100 days and 1 year post transplantation;   Toxicity grade ≥ 3 from start of conditioning through the first year post transplantation;   Cytomegalovirus (CMV) infection and disease assessed weekly for the first 3 months, then every 2 weeks until CD4 > 200;   Disease-free survival with correction of disease at one year post transplantation
33Unknown Autoimmunity-Blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes
Condition:Diabetes Mellitus, Type 1
Interventions:Drug: hOKT3gamma1 (Ala-Ala);   Other: Intensive diabetes management
Sponsors:National Institute of Allergy and Infectious Diseases (NIAID);   Immune Tolerance Network
Gender:Both
Age Groups:Child / Adult
Phase:Phase II
Number Enrolled:81
Funded By:NIH / Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00129259
Other IDs:DAIT ITN027AI
First Received Date:August 9, 2005
Start Date:September 2005
Completion Date:March 2011
Last Updated Date:May 13, 2009
Last Verified Date:March 2009
Acronym:AbATE
Primary Completion Date:March 2011
Outcome Measures:Change from baseline of the mean C-peptide 4-hour area under the curve (AUC) in response to a mixed meal tolerance test (MMTT);   Diabetes-related endpoints, including insulin use, time to undetectable C-peptide response, and HbA1C level;   pharmacokinetic measures, including drug levels, adverse events, Epstein-Barr virus (EBV)/cytomegalovirus (CMV) viral loads;   mechanistic assessments, including T cell depletion/repopulation, alterations to cytokine levels, and T cell activation measures
34CompletedThe Tolerance of HIV-Infected Patients With Herpes Group Virus Infections to Oral Doses of FIAU
Conditions:Herpes Simplex;   HIV Infections;   Hepatitis B
Intervention:Drug: Fialuridine
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:Endpoint Classification: Pharmacokinetics Study;   Primary Purpose: Treatment
NCT ID:NCT00000654
Other IDs:ACTG 122 FIAU,   R90-001-01, 02, 03, 04
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:September 1993
Acronym:
Primary Completion Date:
Outcome Measure:
35Active, not recruitingStem Cell Transplantation and T-Cell Add-Back to Treat Bone Marrow Malignancies
Conditions:Leukemia;   Bone Marrow Transplantation
Interventions:Biological: therapeutic allogeneic lymphocytes;   Drug: cyclophosphamide;   Drug: cyclosporine;   Drug: etoposide;   Drug: fludarabine phosphate;   Procedure: allogeneic bone marrow transplantation;   Procedure: peripheral blood stem cell transplantation;   Radiation: radiation therapy
Sponsor:National Heart, Lung, and Blood Institute (NHLBI)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase II
Number Enrolled:50
Funded By: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:NCT00079391
Other IDs:040112,   04-H-0112
First Received Date:March 8, 2004
Start Date:January 2004
Completion Date:December 2008
Last Updated Date:May 19, 2010
Last Verified Date:September 2009
Acronym:
Primary Completion Date:December 2008
Outcome Measures:The proportion of patients who develop full donor T cell chimerism by day 30.;   Acute and chronic graft-versus-host disease. Transplant-related mortality. Overall mortality. Leukemic relapse. CMV reactivation and disease. Graft failure.
36RecruitingInducing Remission in Type 1 Diabetes With Alefacept
Condition:Diabetes Mellitus, Type 1
Interventions:Drug: alefacept;   Drug: placebo (saline)
Sponsors:National Institute of Allergy and Infectious Diseases (NIAID);   Immune Tolerance Network
Gender:Both
Age Groups:Child / Adult
Phase:Phase II
Number Enrolled:66
Funded By:NIH / 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: Treatment
NCT ID:NCT00965458
Other IDs:DAIT ITN045AI
First Received Date:August 22, 2009
Start Date:March 2011
Completion Date:August 2014
Last Updated Date:March 21, 2011
Last Verified Date:March 2011
Acronym:T1DAL
Primary Completion Date:August 2013
Outcome Measures:Mixed-meal tolerance test (MMTT) stimulated 2-hour C-peptide area under the curve (AUC);   MMTT-stimulated peak and 4-hour C-peptide AUC;   MMTT-stimulated 2-hour C-peptide AUC assessed;   Insulin use in units per kilogram body weight per day;   Major hypoglycemic events occurring from randomization;   HbA1C levels;   Rate of injection reactions; defined as fever, chills, headache, nausea, vomiting, and injection-site pain in participants receiving alefacept or placebo.;   Rate of hypersensitivity reactions; defined as signs and symptoms of anaphylaxis, wheezing, dyspnea, urticaria, and hypotension in participants receiving alefacept or placebo.;   Rate of evidence of infection with Epstein-Barr virus (EBV), Cytomegalovirus (CMV), or Tuberculosis (TB) in participants receiving alefacept or placebo.;   Frequency and severity of all AEs in participants receiving alefacept or placebo
37Active, not recruitingSafety and Efficacy of Alemtuzumab in Pediatric Intestinal Transplantation
Conditions:Transplantation;   Rejection;   Alemtuzumab
Intervention:Drug: Alemtuzumab
Sponsor:University of Pittsburgh
Gender:Both
Age Groups:Child / Adult
Phase:Phase II
Number Enrolled:23
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:NCT01208337
Other IDs:IRB0701088
First Received Date:September 22, 2010
Start Date:April 2007
Completion Date:November 2014
Last Updated Date:March 14, 2011
Last Verified Date:March 2011
Acronym:
Primary Completion Date:March 2010
Outcome Measure:Incidence and severity of biopsy-proven acute cellular rejection






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