A PHASE II DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE

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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 has been designed to determine if the immune responses elicited by antiretroviral immunotherapy (ARI) are capable of maintaining viral suppression following interruption of antiretroviral therapy (ART). Following the immunization phase of the study, there will be a 16-week ART interruption phase. Subjects will then enter a follow-up phase during which time they will either continue the interruption or will resume ART. This will be followed by a long-term safety follow-up phase. Subjects will receive a series of three immunizations with the MRK Ad5 HIV-gag vaccine or a placebo. The study duration will be approximately 240 weeks with the main study evaluations being conducted through week 87 with follow-up occurring for approximately 150 additional weeks. The sample size will be 120 subjects with participants being randomized to the vaccine at a 2 to 1 ratio; up to ten subjects are expected to enroll locally.