Conditions: Acquired Immunodeficiency Syndrome HIV Infections
Keywords: HIV-1 HIV Treatment-Naive Women WAVES
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 583
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the efficacy of a regimen containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) versus ritonavir (RTV)-boosted atazanavir (ATV/r) plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in HIV-1 infected, antiretroviral treatment-naive adult women.

Detailed description:

Arms:
arm 1: E/C/F/TDF + ATV placebo + RTV placebo + FTC/TDF placebo arm 2: ATV + RTV + FTC/TDF + E/C/F/TDF placebo arm 3: After 48 weeks of blinded treatment, participants will continue to take blinded study drug for 12 weeks and return for an unblinding visit at Week 60. Participants who are virologically suppressed at Week 48 during the double-blinded treatment phase will have the option to enter the open-label extension phase. Participants randomized to the E/C/F/TDF arm will continue to receive open-label E/C/F/TDF and participants randomized to the ATV+ RTV + FTC/TDF arm will be re-randomized to receive either open-label elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) or open-label ATV + RTV+ FTC/TDF.

Interventions: intervention 1: E/C/F/TDF intervention 2: ATV intervention 3: RTV intervention 4: FTC/TDF intervention 5: E/C/F/TDF Placebo intervention 6: ATV Placebo intervention 7: RTV Placebo intervention 8: FTC/TDF Placebo intervention 9: E/C/F/TAF
Intervention descriptions: intervention 1: 150/150/200/300 mg FDC tablet administered orally with food once daily intervention 2: 300 mg capsule administered orally with food once daily intervention 3: 100 mg tablet administered orally with food once daily intervention 4: 200/300 mg tablet administered orally with food once daily intervention 5: Tablet administered orally with food once daily intervention 6: Tablet administered orally with food once daily intervention 7: Capsule administered orally with food once daily intervention 8: Tablet administered orally with food once daily intervention 9: 150/150/200/10 mg FDC tablet administered orally with food once daily

Protocol document: