Trials / Completed
CompletedNCT02605954
Safety and Efficacy of Switching From Regimens of ABC/3TC + a 3rd Agent to E/C/F/TAF Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV 1 Infected Adults
A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Abacavir/Lamivudine (ABC/3TC) Plus a Third Antiretroviral Agent to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV 1 Infected Adult Subjects
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 275 (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 efficacy of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) relative to continuing on a baseline regimen consisting of abacavir/lamivudine (ABC/3TC) plus a 3rd antiretroviral agent in HIV-1 infected participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | E/C/F/TAF | 150/150/200/10 mg FDC tablets administered orally once daily |
| DRUG | ABC/3TC | 600/300 mg tablets administered orally once daily |
| DRUG | Third Antiretroviral Agent | Third antiretroviral agents could include one of the following: * ATV+cobicistat (COBI; Tybost®) or ATV/COBI FDC * DRV+COBI or DRV/COBI FDC * darunavir (DRV; Prezista®) + RTV * lopinavir/ritonavir (LPV/r; Kaletra®) * atazanavir (ATV; Reyataz®) + ritonavir (RTV; Norvir®) * efavirenz (EFV; Sustiva®) * etravirine (ETR; Intelence®) * nevirapine (NVP; Viramune®) * rilpivirine (RPV; Edurant®) * dolutegravir (DTG; Tivicay®) * raltegravir (RAL; Isentress®) * fosamprenavir (FPV; Lexiva®) + RTV * saquinavir (SQV; Invirase®) + RTV * ATV (no booster) Drug classes: * Protease inhibitors (PI): LPV/r, ATV, RTV, ATV, DRV, FPV and SQV * Pharmacokinetic enhancer: COBI * Non-nucleoside reverse transcriptase inhibitors (NNRTI): EFV, RPV, NVP, and ETR * Integrase inhibitors: RAL and DTG |
Timeline
- Start date
- 2015-11-18
- Primary completion
- 2017-06-14
- Completion
- 2018-01-24
- First posted
- 2015-11-17
- Last updated
- 2018-11-14
- Results posted
- 2018-07-13
Locations
49 sites across 6 countries: United States, France, Germany, Italy, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02605954. Inclusion in this directory is not an endorsement.