Trials / Completed
CompletedNCT01818596
Open-label Safety Study of E/C/F/TAF (Genvoya®) in HIV-1 Positive Patients With Mild to Moderate Renal Impairment
A Phase 3 Open-label Safety Study of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1 Positive Patients With Mild to Moderate Renal Impairment
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 252 (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 effect of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) tablet on renal parameters at Week 24 in treatment-naive and treatment-experienced HIV-positive, adults with mild to moderate renal impairment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | E/C/F/TAF | E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food |
Timeline
- Start date
- 2013-03-27
- Primary completion
- 2014-07-31
- Completion
- 2018-07-18
- First posted
- 2013-03-26
- Last updated
- 2020-03-02
- Results posted
- 2016-02-18
Locations
70 sites across 9 countries: United States, Australia, Dominican Republic, France, Mexico, Netherlands, Spain, Thailand, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01818596. Inclusion in this directory is not an endorsement.