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
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.
Timeline
- Start
- 2018-04-03
- Primary completion
- 2019-12-09
- Completion
- 2019-12-09
Outcome
Outcome not reported
Stopped: “GS-9131 did not meet the targeted antiviral response”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ROVAFOVIR ETALAFENAMIDE | Small molecule | 60 mg | Oral |
| Subject | ROVAFOVIR ETALAFENAMIDE | Small molecule | 180 mg | Oral |
| Background | BIC | Unknown | 30 mg | Oral |
| Background | BIC | Unknown | 75 mg | Oral |
| Background | DRV | Unknown | 800 mg | Oral |
| Background | RTV | Unknown | 100 mg | Oral |
| Background | TAF | Unknown | 25 mg | Oral |