Trials / Completed
CompletedNCT02276612
Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Adolescents
A Phase 2/3, Open-Label Study to Evaluate the Safety and Efficacy of E/C/F/TAF in HIV-1 Infected Virologically Suppressed Adolescents
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 12 Years – 17 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) in HIV-infected virologically suppressed adolescents 12 to \< 18 years of age.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | E/C/F/TAF | 150/150/200/10 mg fixed-dose combination (FDC) tablet administered orally once daily with food |
Timeline
- Start date
- 2014-12-03
- Primary completion
- 2016-11-10
- Completion
- 2017-10-23
- First posted
- 2014-10-28
- Last updated
- 2018-11-19
- Results posted
- 2018-02-22
Locations
7 sites across 2 countries: United States, South Africa
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02276612. Inclusion in this directory is not an endorsement.