Trials / Terminated
TerminatedNCT03472326
Study to Evaluate the Efficacy of GS-9131 Functional Monotherapy in Human Immunodeficiency Virus (HIV)-1-Infected Adults Failing a Nucleos(t)Ide Reverse Transcriptase Inhibitor-Containing Regimen With Nucleos(t)Ide Reverse Transcriptase Inhibitor Resistant Virus
A Phase 2 Study to Evaluate the Efficacy of GS-9131 Functional Monotherapy in HIV-1-Infected Adults Failing a Nucleos(t)Ide Reverse Transcriptase Inhibitor-Containing Regimen With Nucleos(t)Ide Reverse Transcriptase Inhibitor Resistant Virus
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the short-term antiviral potency of GS-9131 functional monotherapy compared to placebo-to-match (PTM) GS-9131, each administered once daily with the existing failing antiretroviral (ARV) regimen as demonstrated by the proportion of participants achieving human immunodeficiency virus ribonucleic acid (HIV-1 RNA) \> 0.5 log10 decreases from baseline after up to 14 days of therapy in HIV-1 positive, ARV treatment experienced adult participants with nucleos(t)ide resistant virus. This is a two-part study. Part 1 consists of three cohorts: 2 Sentinel Cohorts and 1 Randomized Cohort. Eligible participants from Part 1 will proceed to Part 2 followed by an optional open-label extension.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GS-9131 | Tablet(s) administered orally once daily |
| DRUG | BIC | Tablet(s) administered orally once daily |
| DRUG | TAF | Tablet(s) administered orally once daily |
| DRUG | ARV regimen | ARV regimen may consist of the ARV agents containing nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitor (NNRTI) |
| DRUG | DRV | Tablet(s) administered orally once daily |
| DRUG | RTV | Tablet(s) administered orally once daily |
Timeline
- Start date
- 2018-04-03
- Primary completion
- 2019-12-09
- Completion
- 2019-12-09
- First posted
- 2018-03-21
- Last updated
- 2021-01-05
- Results posted
- 2021-01-05
Locations
2 sites across 2 countries: Uganda, Zimbabwe
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03472326. Inclusion in this directory is not an endorsement.