CLINICAL TRIAL: ACTG A5197: ANTIRETROVIRAL EFFECT OF IMMUNIZATION WITH THE MRK A

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study hypothesizes that stimulation of HIV gag-specific CD8 cells by an Adenovirus-HIVgag vector (Ad5 HIV-1 GAG) will result in better virologic control of autologous HIV in individuals who had previously suppressed HIV replication for >24 months with antiretroviral therapy. Design: Step 1 - A Merck vaccine or placebo (120 patients randomized in 2:1 ratio to these treatments) is delivered at 0, 4, and 26 weeks; this is followed by a 16-week antiretroviral treatment interruption and monitored for safety by frequent CD4 and HIV RNA measurements (step 2). If the subjects choose to remain off antiretroviral therapy (ART), they continue off ART for additional 8-week renewable intervals (up to 32 weeks). If they (or their clinician) choose to resume ART (recommended criteria are CD4 count drops to <50% of baseline, <300, or HIV RNA>300,000 3 consecutive times, signs or symptoms of clinically significant immunosuppression), they enroll in step 4, restarting ART with evaluations at 8-week intervals (up to week 87 of the study). There is a long-term safety step (5), which evaluates patients every 6 months. Endpoints: Primary - the HIV RNA setpoint (determined by the mean of the log copies/ml at weeks 12 and 16 of step 2 and the RNA values at all evaluations during step 2. Secondary endpoints include changes in setpoint, a variety of HIV-specific immunologic assays, and safety data.