Trials / Completed
CompletedNCT02480712
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection
A Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 107 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in participants with chronic HCV infection who were coinfected with HIV-1.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SOF/VEL | 400/100 mg fixed-dose combination (FDC) tablet administered orally once daily |
Timeline
- Start date
- 2015-07-01
- Primary completion
- 2016-04-29
- Completion
- 2016-06-22
- First posted
- 2015-06-24
- Last updated
- 2018-11-16
- Results posted
- 2017-06-01
Locations
15 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02480712. Inclusion in this directory is not an endorsement.