Study:
A Phase II Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Antiretroviral Effect of Immunization With the MRK Ad5 HIV-1 Gag Vaccine in HIV-1 Infected Individuals Who Interrupt Antiretroviral Therapy
Rationale:
n/a
Purpose:
HIV vaccines may help the immune systems of HIV infected patients better control the virus.
The goal of this study is to determine whether patients on anti-HIV medications can stop
taking those medications if they receive an HIV vaccine. While taking anti-HIV medications,
participants will receive either an HIV vaccine or a placebo. Participants will then stop
taking their anti-HIV medications and the study will compare the viral loads of participants
who received the vaccine with the viral loads of participants who received the placebo.
Primary study hypotheses: 1)The Week 12 and Week 16 post-ART interruption geometric mean
HIV-1 RNA levels will be lower among participants who had received MRK Ad5 vaccine prior to
ART interruption than among participants who received placebo; 2) the time averaged area
under the curve of the log10 HIV-1 RNA copies/ml versus day function in the 16 week post-ART
interruption step will be lower among participants who received the MRK Ad5 vaccine prior to
ART interruption than among participants who receive placebo.
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
HIV Infections |
Biological: MRK Ad5 HIV-1 gag vaccine
Other: Vaccine placebo |
Phase 2 |
Verified by
National Institute of Allergy and Infectious Diseases (NIAID)
February, 2012
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov identifier: NCT00080106
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Cleveland Clinic Foundation, Div. of Medicine, Infectious Diseases
Cleveland, Ohio 44195
United States
Robert T. Schooley, MD., Study Chair