A5202

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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. DESIGN A5202 is a phase IIIB, randomized, four-arm study, comparing the efficacy, safety, and tolerability of open-label ritonavir (RTV)-enhanced atazanavir (ATV) to efavirenz (EFV), in combination with either daily emtricitabine (FTC)/tenofovir (TDF) or abacavir (ABC)/lamivudine (3TC) and of partially blinded ABC/3TC compared to FTC/TDF in combination with either RTV-enhanced ATV or EFV as initial therapy for HIV-1 infection. DURATION: Approximately 96 weeks beyond the enrollment of the last subject. SAMPLE SIZE: A5202 will enroll 1800 subjects (450 per treatment arm). POPULATION: HIV-1-infected, antiretroviral (ARV) drug-na¿ve men and women e16 years of age with plasma HIV-1 RNA levels 1000 copies/mL obtained within 90 days prior to study entry. REGIMEN At entry subjects will be randomized to one of the following: 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 The three primary objectives are: 1. To compare virologic efficacy between regimens with virologic failure defined as the time to confirmed plasma HIV-1 RNA level e1000 copies/mL at or after 16 weeks and before 24 weeks or e200 copies/mL at or after week 24. 2. To compare the safety between regimens with safety defined as the time to first development of Grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline. 3. To compare the tolerability between regimens with tolerability defined as the time to change in one or more drugs in the initial treatment regimen