Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults
Completed · Phase 3
Conditions studied: HIV-1, HIV Infections, Acquired Immunodeficiency Syndrome
In brief
The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed dose combination (FDC) plus darunavir (DRV) relative to current antiretroviral regimens (ARV) in virologically suppressed, HIV-1 positive participants with HIV-1 RNA \<50 copies/mL at Week 24. This study consists of 48 weeks of open-label phase followed by an optional Extension Phase in which all the participants will receive E/C/F/TAF+DRV.
Key facts
- Study ID
- NCT01968551
- Run by
- Gilead Sciences
- People needed
- 158
- Starts
- 2013-09-03
- Expected to finish
- 2016-07-09
- Last updated by the study team
- 2018-11-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Pacific Oaks Medical Group — Beverly Hills, California, United States
- Kaiser Permanente — Hayward, California, United States
- Long Beach Education and Research Consultants — Long Beach, California, United States
- Peter J Ruane, MD, Inc. — Los Angeles, California, United States
- Kaiser Permanente Medical Group — Sacramento, California, United States
- Kaiser San Francisco Division of Research — San Francisco, California, United States
- Dupont Circle Physician's Group — Washington D.C., District of Columbia, United States
- Midland Florida Clinical Research Center, LLC — DeLand, Florida, United States
- Therafirst Medical Center — Fort Lauderdale, Florida, United States
- Gary J.Richmond, MD, P.A. — Fort Lauderdale, Florida, United States
- Midway Immunology and Research Center — Ft. Pierce, Florida, United States
- Orlando Immunology Center — Orlando, Florida, United States
- Valuhealthmd/Idocf — Orlando, Florida, United States
- Infectious Diseases Associates of NW FL — Pensacola, Florida, United States
- Hillsborough County Health Department — Tampa, Florida, United States
- St. Joseph's Comprehensive Research Institute — Tampa, Florida, United States
- AIDS Research and Treatment Center of the Treasure Coast — Vero Beach, Florida, United States
- Triple O Research Institute PA — West Palm Beach, Florida, United States
- Atlanta ID Group — Atlanta, Georgia, United States
- AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
- Mercer University, Mercer Medicine — Macon, Georgia, United States
- The Ruth M. Rothstein CORE Center — Chicago, Illinois, United States
- Howard Brown Health Center — Chicago, Illinois, United States
- Johns Hopkins University — Lutherville, Maryland, United States
- Pueblo Family Physicians, Ltd. — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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