A5095: PHASE III, RANDOMIZED, DOUBLE-BLIND COMPARISON OF THREE PI-SPARING

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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. AIDS Clinical Trials Group Study A5095 is a phase III, multicenter, randomized, double-blind comparison of 3 HIV protease inhibitor-sparing regimens for the initial treatment of HIV infection. The 3 regimens are: (1) zidovudine/lamivudine/abacavir (co-formulated); (2) zidovudine/lamivudine (co-formulated) + efavirenz; and (3) zidovudine/lamivudine/abacavir (co-formulated) + efavirenz The specific primary objectives of this study are: to compare the ability of the three initial protease-inhibitor-sparing antiretroviral regimens to suppress and maintain HIV-1 RNA<200 copies/mL (time to virologic failure), and to determine the safety and tolerability of the three initial protease-inhibitor sparing regimens.