A PHASE III B, RANDOMIZED, TRIAL OF OPEN-LABEL EFAVIRENZ OR ATAZANAVIR WITH RITO

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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. 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. Subjects will participate in A5202 for approximately 96 weeks beyond the enrollment of the last subject. Accrual is anticipated to take 96 weeks, resulting in an estimated total study duration of approximately 192 weeks. A5202 will enroll 1800 subjects (450 per treatment arm). HIV-1-infected, antiretroviral (ARV) drug-na¿ve (?7 days of ARV treatment at any time prior to study entry) men and women ?16 years [? 18 ears locally] of age with plasma HIV-1 RNA levels 1000 copies/mL obtained within 90 days prior to study entry. Subjects will be stratified at screening based on plasma HIV-1 RNA levels 100,000 and ?100,000 copies/mL and intent and eligibility to enroll in the metabolic substudy A5224s; Long-Term Metabolic Assessments in Subjects Treated with Emtricitabine/Tenofovir or Abacavir/Lamivudine with either Efavirenz or Atazanavir with Ritonavir.