Trials / Completed
CompletedNCT02469246
Switch Study to Evaluate F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed on Regimens Containing ABC/3TC
A Phase 3b, Randomized, Double-Blind, Switch Study to Evaluate F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed on Regimens Containing ABC/3TC
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 567 (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 switching abacavir/lamivudine (ABC/3TC) fixed-dose combination (FDC) tablets to emtricitabine/tenofovir alafenamide (F/TAF) FDC tablets versus maintaining ABC/3TC in human immunodeficiency virus type 1 (HIV-1) infected adults who are virologically suppressed on regimens containing ABC/3TC.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | F/TAF | 200/10 mg FDC tablet (with boosted 3rd ARV agents) or 200/25 mg FDC tablet (with unboosted 3rd ARV agents) administered orally once daily |
| DRUG | ABC/3TC | 600/300 mg FDC tablets administered orally once daily |
| DRUG | ABC/3TC Placebo | Tablets administered orally once daily |
| DRUG | F/TAF Placebo | Tablets administered orally once daily |
| DRUG | 3rd ARV agent | An allowed 3rd ARV agent of the participant's pre-existing regimen may include one of the following boosted ARV agents: ritonavir boosted lopinavir (LPV/r), atazanavir (ATV) + ritonavir (RTV), ATV + cobicistat (COBI) or ATV/COBI FDC, darunavir (DRV) + RTV, DRV+COBI or DRV/COBI FDC; or, one of the following unboosted ARV agents: efavirenz (EFV), rilpivirine (RPV), raltegravir (RAL), dolutegravir (DTG), maraviroc (MVC), or nevirapine (NVP). |
Timeline
- Start date
- 2015-06-29
- Primary completion
- 2017-12-11
- Completion
- 2019-03-13
- First posted
- 2015-06-11
- Last updated
- 2019-10-25
- Results posted
- 2018-06-11
Locations
80 sites across 12 countries: United States, Belgium, Canada, Denmark, France, Germany, Ireland, Italy, Puerto Rico, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02469246. Inclusion in this directory is not an endorsement.