ANTIRETROVIRAL EFFECT OF IMMUNIZATION WITH THE MRK AD5 HIV-1 GAG VACCINE

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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 is a phase II, randomized, double-blind, multicenter, placebo-controlled study designed to determine if the immune responses elicited by antiretroviral immunotherapy (ARI) are capable of maintaining viral suppression following interruption of antiretroviral therapy (ART). The study will be conducted in four phases: 1) an immunization phase (Step I), 2) a 16-week ART interruption phase (Step II), 3) a follow-up phase, either continuation of the interruption of all ART (Step III) or resumption of ART (Step IV), and 4) a long-term safety follow-up phase (Step V). While on ART in Step I, subjects will receive a series of three immunizations with the MRK Ad5 HIV-1 Gag vaccine or placebo. After the immunization phase, all subjects who meet the criteria will enter Step II and will be followed clinically, immunologically, and virologically. After the 16-week ART interruption phase, subjects will have the option to resume ART or continue off ART. . Subjects on Step II/III whose HIV-1 RNA is ? 300,000 copies/mL three consecutive times or who have a confirmed (defined as two consecutive values) CD4+ cell count of 50% from baseline will be strongly encouraged to resume ART (see section 3.0 for further details). After completion of Step III or Step IV or after the last visit on Step I (if ineligible for Step II) subjects will be followed for long-term safety assessments (Step V).