Valganciclovir to Reduce T Cell Activation in HIV Infection
|ClinicalTrials.gov Identifier: NCT00264290|
Recruitment Status : Completed
First Posted : December 12, 2005
Results First Posted : November 8, 2013
Last Update Posted : December 3, 2013
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections Cytomegalovirus Infections||Drug: Valganciclovir Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Valganciclovir to Reduce T Cell Activation in HIV Infection|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||November 2008|
900mg PO qd
900mg PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone.
Placebo Comparator: Placebo
900mg PO qd
Placebo designed to resemble Valganciclovir
- Change in %CD38+ Human Leukocyte Antigen-D-related (HLA-DR)+ CD8+ T Cells From Baseline to Week 8. [ Time Frame: Baseline, 8 weeks ]The percentage of activated (CD38+ HLA-DR+) CD8+ T cells was measured on fresh whole blood at screening/baseline. T cell activation was measured on peripheral blood mononuclear cells (PBMCs)in batch at the end of the study.
- Change in CMV DNA Shedding From Baseline to Week 8. [ Time Frame: week 8 ]Change in percentage of participants with detectable CMV DNA. Herpesvirus DNA levels were assessed by polymerase chain reaction (lower limit of detection, 150 copies/mL) on saliva and seminal plasma.
- Change in Cluster of Differentiation 4 (CD4) Counts and Plasma HIV RNA Levels at Week 8. [ Time Frame: week 8 ]
- %CD38+HLA-DR+ CD8+ T Cells After a 4-week Washout Period [ Time Frame: Week 12 ]
- Change in CMV DNA Shedding After a 4-week Washout Period [ Time Frame: Week 12 ]
- Change in CD4 Counts and Plasma HIV RNA Levels After a 4-week Washout Period [ Time Frame: Week 12 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00264290
|United States, California|
|San Francisco General Hospital - General Clinical Research Center|
|San Francisco, California, United States, 94110|
|Principal Investigator:||Peter W. Hunt, M.D.||University of California, San Francisco|