A5202, FINAL VERSION 10, 05/05/05: INITIAL THERAPY WITH DIFFERENT ANTIRETROVIRA

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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 IIIB, randomized, partially blinded study comparing the efficacy, safety, and tolerability of four ARV regimens: ARM A: EFV 600 mg QD + FTC 200 mg/TDF 300 mg QD + ABC/3TC placebo QD ARM B: EFV 600 mg QD + ABC 600 mg/3TC 300 mg QD + FTC/TDF placebo QD ARM C: ATV 300 mg QD with RTV 100 mg QD + FTC 200 mg/TDF 300 mg QD + ABC/3TC placebo QD ARM D: ATV 300 mg QD with RTV 100 mg QD + ABC 600 mg/3TC 300 mg QD + FTC/TDF placebo QD Eligible subjects will be ARV drug-naive (< days of ARV treatment at any time prior to entry*) with plasma HIV-1 RNA >1000 copies/ml obtained within 90 days prior to study entry. There will be no CD4+ T-cell count restriction. *The only exceptions are: (1)Use of antivirals as part of post-exposure prophylaxis (PEP) provided the subject did not acquire HIV-1 infection fkom the event that required PEP. (2) Therapy with an investigational ARV drug that was not an NRTI, NNRTI, or PI. 1800 subjects (450 per study arm) will enroll over approximately 96 weeks. Subjects will be stratified by HIV-1 RNA level at screening (<100,000 copies/ml versus >100,000 copies/ml) and intent and eligibility to enroll in the metabolic substudy A5224s. Subjects will be followed for approximately 96 weeks after the last subject is enrolled. This study has been granted IND exempt status.