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 will compare three protease inhibitor (PI) -sparing treatment options for the initial treatment of HIV-1 infection. The goal of therapy will be to suppress and maintain HIV-1 RNA levels < 200 copies/ml. This study would also determine the safety and tolerability of the three PI-sparing regimens. 1. Hypothesis Three primary efficacy hypotheses will be evaluated in this study. Hypothesis I: Ho: The rate of virologic failure in the ABC/3TC/ZDV arm is greater than the rate of virologic failure in the 3TC/ZDV/EFV arm. H1: The rate of virologic failure in the ABC/3TC/ZDV is not inferior to the rate of virologic failure in the 3TC/ZDV/EFV arm. NOTE: This trial will not evaluate whether there is a lower rate of virologic failure in the ABC/3TC/ZDV compared to the 3TC/ZDV/EFV arm. Hypothesis II: Ho:There is no difference in the distribution of time to virologic failure in the ABC/3TC/ZDV/EFV and the 3TC/ZDV/EFV arms. H1: There is a difference in the distribution of time to virologic failure in the ABC/3TC/ZDV/EFV and the 3TC/ZDV/EFV arms. Hypothesis III: Ho: here is no difference in the distribution of time to virologic failure in the ABC/3TC/ZDV/EFV and the ABC/3TC/ZDV arms. H1: There is a difference in the distribution of time to virologic failure in the ABC/3TC/ZDV/EFV and the ABC/3TC/ZDV arms. 2.
Specific Aims A5095: The primary objectives of this study are to 1) to compare the ability of the three initial PI-sparing antiretroviral regimens to suppress and maintain HIV-1 RNA <200 copies/mL (time to failure). 2) To determine the safety and tolerability of the three initial PI-sparing regimens. A5097: The primary objectives of this study are to 1)To describe the incidence, duration, and cognitive motor effect of neurologic symptoms and signs associated with initiation of EFV therapy compared to therapy without EFV. 2) To correlate these findings with EFV serum drug levels over the initial 24 weeks of treatment. A5107: The primary objectives of this study are to 1) To describe the absorption and disposition characteristics of BMS-232632 in 25 HIV-positive subjects. 2) To investigate concentration-response relationships of BMS-232632 in patients who have previously failed non-PI-containing regimens. 3) To explore relationships between plasma BMS-232632 pharmacokinetic parameters and changes in bilirubin.
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