Trials / Completed
CompletedNCT02345252
Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Adults Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)
A Phase 3b, Randomized, Double-Blind Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Subjects Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 632 (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 noninferiority of switching to emtricitabine/rilpivirine /tenofovir alafenamide (FTC/RPV/TAF) fixed-dose combination (FDC) as compared to continuing FTC/RPV/tenofovir disoproxil fumarate (TDF) FDC (FTC/RPV/TDF) in virologically suppressed HIV-1 infected participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FTC/RPV/TAF | 200/25/25 mg FDC tablets administered orally once daily |
| DRUG | FTC/RPV/TDF Placebo | Tablets administered orally once daily |
| DRUG | FTC/RPV/TDF | 200/25/300 mg FDC tablets administered orally once daily |
| DRUG | FTC/RPV/TAF Placebo | Tablets administered orally once daily |
Timeline
- Start date
- 2015-01-26
- Primary completion
- 2016-06-22
- Completion
- 2019-01-09
- First posted
- 2015-01-26
- Last updated
- 2020-01-02
- Results posted
- 2017-12-08
Locations
117 sites across 12 countries: United States, Belgium, Canada, France, Germany, Italy, Netherlands, Puerto Rico, Spain, Sweden, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02345252. Inclusion in this directory is not an endorsement.