Conditions: HIV-1 Infection
Keywords: HIV HIV-1 Antiretroviral Treatment-Naive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 85
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) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF in HIV-1 infected, antiretroviral treatment-naive adults.

Participants will be randomized in a 2:1 ratio. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or \> 100,000 copies/mL) at screening. After Week 48, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments are unblinded, at which point all participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive ATV+COBI+FTC/TDF until COBI tablets become commercially available, or until Gilead Sciences elects to terminate the study.

Detailed description:

Arms:
arm 1: COBI + RTV placebo +ATV+FTC/TDF for 48 weeks arm 2: RTV + COBI placebo +ATV+FTC/TDF for 48 weeks

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 soft gelatin capsule 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: