Conditions: HIV HIV Infections
Keywords: Treatment Naive HIV 1 Infected
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 698
Healthy volunteers: no

Brief summary:
The objective of this study is to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) fixed-dose combination (FDC) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF FDC in HIV-1 infected, antiretroviral treatment-naive adults.

Participants will be randomized in a 1:1 ratio. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or \> 100,000 copies/mL) at screening.

Detailed description:

Arms:
arm 1: COBI + RTV placebo + ATV + FTC/TDF once daily arm 2: RTV + COBI placebo + ATV + FTC/TDF once daily

Interventions: intervention 1: COBI intervention 2: RTV intervention 3: ATV intervention 4: FTC/TDF intervention 5: COBI placebo intervention 6: RTV placebo
Intervention descriptions: intervention 1: Cobicistat (COBI) 150 mg tablet administered orally once daily intervention 2: Ritonavir (RTV) 100 mg tablet administered orally once daily intervention 3: Atazanavir (ATV) 300 mg capsule administered orally once daily intervention 4: Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination tablet administered orally once daily intervention 5: Placebo to match COBI administered orally once daily intervention 6: Placebo to match RTV administered orally once daily

Protocol document: