Conditions: HIV HIV Infections
Keywords: HIV HIV 1 Infected Virologically-Suppressed
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1443
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected participants as determined by having HIV-1 RNA \< 50 copies/mL at Week 48.

Detailed description:

Arms:
arm 1: Randomized Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) for up to 96 weeks.

Extension Phase: After completing 96 weeks of randomized treatment, all participants will be given the opportunity to receive open-label E/C/F/TAF until it becomes commercially available, or until Gilead elects to terminate the development of E/C/F/TAF. arm 2: Randomized Phase: Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks.

Extension Phase: After completing 96 weeks of randomized treatment (SBR), all participants will be given the opportunity to receive open-label E/C/F/TAF until it becomes commercially available, or until Gilead elects to terminate the development of E/C/F/TAF.

Interventions: intervention 1: E/C/F/TAF intervention 2: E/C/F/TDF intervention 3: EFV/FTC/TDF intervention 4: RTV intervention 5: ATV intervention 6: FTC/TDF intervention 7: COBI
Intervention descriptions: intervention 1: 150/150/200/10 mg FDC tablet administered orally once daily intervention 2: 150/150/200/300 mg FDC tablet administered orally once daily intervention 3: 600/200/300 mg FDC tablet administered orally once daily intervention 4: 100 mg tablet administered orally once daily intervention 5: 300 mg capsule administered orally once daily intervention 6: 200/300 mg tablet administered orally once daily intervention 7: 150 mg tablet administered orally once daily

Protocol document: