At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 19 enrolled
Drug / intervention
Bictegravirdrug
Likely dose
Bictegravir 75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Open-Label, Parallel-Group, Adaptive Single-dose Study to Evaluate the Pharmacokinetics of GS-9883 in Subjects With Normal and Impaired Renal Function
In Brief
A Phase 1 clinical trial evaluating Bictegravir for HIV. Completed, enrolled 19 participants across 7 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesNew Zealand, United States
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 2015
Enrollment StartApr 2015
Primary CompletionJul 2015
Study CompletionJul 2015
TodayJul 2026
First PostedMar 27, 2015
Enrollment StartApr 17, 2015
Primary CompletionJul 6, 2015
Study CompletionJul 13, 2015
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 11.3 years ago
Interventions
Bictegravirdrug
75 mg tablet administered orally