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 randomized phase I/II pilot study intended to evaluate the safety, antiviral effects and immunological effects of intermittent withdrawal of potent antiretroviral therapy as an immunization strategy, ALVAC-HIV immunization, and the two strategies combined. One hundred HIV-infected subjects will be enrolled. Subjects currently receiving their first potent antiretroviral treatment (potent ART), defined as three-or-more-drug combination antiretroviral therapy regimen, with persistent CD4+ T-cell counts > 400 cells/mm^3 for more than 6 months before study entry. HIV-1 RNA levels < 400 copies/mL for more than 6 months before study entry and < 50 copies/mL at study screening required. The duration of the study will be approximately 2 years. Subjects will be randomized in equal numbers (25 per arm) to one of four arms: Arm A: Placebo immunization (ALVAC placebo) + potent ART for 92 weeks with one 12-20 week therapy withdrawal period. Arm B: Placebo immunization (ALVAC placebo) + potent ART for 84 weeks with one 4-6 week therapy withdrawal period, one 4-week therapy withdrawl period, and one 12-20 week withdrawal period. Arm C: Vaccine immunization (ALVAC vCP1452) + potent ART for 92 weeks with one 12-20 week therapy withdrawal period. Arm D: Vaccine immunization (ALVAC vCP1452) + potent ART for 84 weeks with one 4-6 week therapy withdrawal period, one 4-week therapy withdrawal period, and one 12-20 week therapy withdrawal period. This study will be managed as a multiple-step study. For subjects in Arms B and D, periods on potent ART therapy while receiving ALVAC immunizations will be followed by alternating periods of therapy withdrawal and resumption. Subjects in Arms A and C will remain on potent ART with three sets of vaccine administrations for the first 44 weeks on study. Following 44-46 weeks on study, subjects in all arms will then have therapy withdrawn for a period depending on viral response and CD4+ counts. There are 3 body compartment substudies of A5068 which will quantitate the size of the latently infected cell population.
Showing the most recent 10 out of 767 publications
