Conditions: Acquired Immunodeficiency Syndrome HIV Infections
Keywords: HIV-1 HIV Treatment-Naive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 153
Healthy volunteers: no

Brief summary:
This study is to evaluate the safety and efficacy darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus darunavir (DRV)+cobicistat (COBI)+emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) in HIV-1 infected, antiretroviral treatment-naive adults as determined by the achievement of HIV-1 RNA \< 50 copies/mL at Week 24.

Detailed description:

Arms:
arm 1: D/C/F/TAF FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo arm 2: DRV tablet plus COBI tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo

Interventions: intervention 1: D/C/F/TAF intervention 2: DRV intervention 3: COBI intervention 4: FTC/TDF intervention 5: D/C/F/TAF Placebo intervention 6: DRV Placebo intervention 7: COBI Placebo intervention 8: FTC/TDF Placebo
Intervention descriptions: intervention 1: DRV 800 mg/COBI 150 mg/FTC 200 mg/TAF 10 mg FDC tablet administered orally once daily intervention 2: DRV 800 mg (2 × 400 mg tablets) administered orally once daily intervention 3: COBI 150 mg tablet administered orally once daily intervention 4: FTC 200 mg/TDF 300 mg FDC tablet administered orally once daily intervention 5: D/C/F/TAF placebo tablet administered orally once daily intervention 6: DRV placebo tablet administered orally once daily intervention 7: COBI placebo tablet administered orally once daily intervention 8: FTC/TDF placebo tablet administered orally once daily

Protocol document: