Trials / Completed
CompletedNCT02275065
Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Bictegravir (GS-9883) in Human Immunodeficiency Virus (HIV)-1 Infected Participants
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bictegravir | Bictegravir tablet(s) administered orally once daily |
| DRUG | Placebo | Placebo to match bictegravir administered orally once daily |
Timeline
- Start date
- 2014-10-24
- Primary completion
- 2015-01-23
- Completion
- 2015-01-29
- First posted
- 2014-10-27
- Last updated
- 2020-11-09
- Results posted
- 2020-10-08
Locations
16 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02275065. Inclusion in this directory is not an endorsement.