Conditions: HIV-1 Infection
Keywords: Adult HIV naive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 98
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy, safety and tolerability of bictegravir (BIC) + emtricitabine/tenofovir alafenamide (F/TAF) fixed dose combination (FDC) versus dolutegravir (DTG) + F/TAF in HIV-1 Infected, antiretroviral treatment-naive adults. This study will also evaluate the pharmacokinetic (PK) profile of BIC, emtricitabine and TAF.

Detailed description:

Arms:
arm 1: Participants will receive BIC + F/TAF FDC + DTG placebo for 48 weeks.

* Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF. arm 2: Participants will receive DTG + F/TAF FDC + BIC placebo for 48 weeks.

* Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive B/F/TAF until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF. arm 3: After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF.

Interventions: intervention 1: BIC intervention 2: F/TAF intervention 3: DTG intervention 4: BIC Placebo intervention 5: DTG Placebo intervention 6: B/F/TAF
Intervention descriptions: intervention 1: 75 mg tablet administered orally once daily intervention 2: 200/25 mg FDC tablet administered orally once daily intervention 3: 50 mg tablet administered orally once daily intervention 4: Tablet administered orally once daily intervention 5: Tablet administered orally once daily intervention 6: 50/200/25 mg FDC tablet administered orally once daily

Protocol document: