Conditions: HIV
Keywords: Phase 1 Renally Impaired
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 19
Healthy volunteers: yes

Brief summary:
The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of oral bictegravir (formerly GS-9883) in adults with impaired renal function relative to matched, healthy controls with normal renal function. Each participant in the renal impairment groups will be matched for age (± 10 years), gender, and body mass index \[BMI (± 20%, 18 ≤ BMI ≤ 40 kg/m\^2)\] with a participant in the control group.

Detailed description:

Arms:
arm 1: Participants with severe renal impairment and matched healthy controls will receive a single dose of bictegravir. arm 2: Participants with moderate renal impairment and matched healthy controls will receive a single dose of bictegravir. arm 3: Participants with mild renal impairment and matched healthy controls will receive a single dose of bictegravir.

Interventions: intervention 1: Bictegravir
Intervention descriptions: intervention 1: 75 mg tablet administered orally

Protocol document: