Trials / Completed
CompletedNCT02600819
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Adults on Chronic Hemodialysis
A Phase 3b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Subjects on Chronic Hemodialysis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV-1) infected adults with end-stage renal disease (ESRD) on chronic hemodialysis (HD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | E/C/F/TAF | 150/150/200/10 mg FDC tablets administered orally once daily |
| DRUG | B/F/TAF | 50/200/25 mg FDC tablets administered orally once daily |
Timeline
- Start date
- 2015-12-14
- Primary completion
- 2017-09-29
- Completion
- 2019-10-15
- First posted
- 2015-11-09
- Last updated
- 2020-11-05
- Results posted
- 2018-10-16
Locations
26 sites across 4 countries: United States, Austria, France, Germany
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02600819. Inclusion in this directory is not an endorsement.