THREE PROTEASE INHIBITOR-SPARING REGIMENS FOR INITIAL RX OF HIV (A5095)

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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 will compare three 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. 1125 subjects will be enrolled over approximately 66 weeks. the subjects will be randomized to one of the following blinded Step 1 treatment arms: Arm A)Abacavir (ABC)/lamivudine (3TC)/Zidovudine (ZDV) BID + 3TC/ZDV placebo BID + Efavirenz (EFV) 600mg QD. Arm B) ABC/3TC/ZDV BID + 3TC/ZDV placebo BID + EFV placebo QD. ARM C) ABC/3TC/ZDV placebo BID + 3TC/ZDV BID + EFV 600mg QD. The subjects will be followed for 96 weeks beyond enrollment of the the last subject. The total study duration will be approximately 3 years. Subjects will confirmatory viral load < 10,00 copies/ml may either remain on step 1 or register to step 2. Step 2 Open Label Treatment includes 2 arms: Arm D) 2 nucleoside reverse-transcriptase inhibitors (Nrtis) + EFV 600 mg QD and Arm E) 2 NRTIs + BMS-232632 400 mg QD. Subjects may also participate in A5097s the substudy-Impact of Efavirenz on Neuropsychological Performance, Mood, and sleep Behavior in HIV-Positive Individuals. This study will describe the incidence, duration, and cognitive motor effects of neurologic symptoms and signs associated with initiation of EFV therapy compared to therapy without EFV. Subjects will complete questionnaires to evaluate this information. Substudy A5107s is a pharmacology substudy to investigate the new protease inhibitor BMS-2326-32.