Conditions: HIV-1 Infection
Keywords: HIV-1 Infected Adults Treatment Naive
Allocation: RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 23
Healthy volunteers: no

Brief summary:
The primary objective of the study is to investigate the short-term antiviral potency of bictegravir at multiple doses in antiretroviral (ART) treatment-naive adult participants and participants who are ART-experienced but integrase strand transfer inhibitor (INSTI) naive.

Detailed description:

Arms:
arm 1: Bictegravir 5 mg (1 × 5 mg tablet) for 10 days arm 2: Bictegravir 25 mg (1 × 25 mg tablet) for 10 days arm 3: Bictegravir 50 mg (2 × 25 mg tablets) for 10 days arm 4: Bictegravir 100 mg (1 × 100 mg tablet) for 10 days arm 5: Placebo matched to bictegravir tablet for 10 days

Interventions: intervention 1: Bictegravir intervention 2: Placebo
Intervention descriptions: intervention 1: Bictegravir tablet(s) administered orally once daily intervention 2: Placebo to match bictegravir administered orally once daily

Protocol document: