At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 23 enrolled
Drug / intervention
Bictegravir +1 moredrug
Likely dose
Not stated in 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 1b Randomized, Double-Blinded, Sequential Cohort Placebo-Controlled Study of the Safety, Pharmacokinetics, and Antiviral Activity of GS-9883 in HIV-1 Infected Subjects
In Brief
A Phase 1 clinical trial evaluating Bictegravir and Placebo for HIV-1 Infection. Completed, enrolled 23 participants across 16 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartOct 2014
First PostedOct 2014
Primary CompletionJan 2015
Study CompletionJan 2015
TodayJul 2026
First PostedOct 27, 2014
Enrollment StartOct 24, 2014
Primary CompletionJan 23, 2015
Study CompletionJan 29, 2015
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 11.7 years ago
Interventions
Bictegravirdrug
Bictegravir tablet(s) administered orally once daily
Placebodrug
Placebo to match bictegravir administered orally once daily