Efficacy, Safety, and Tolerability of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Participants Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) Prior to LDV/SOF HCV Treatment
Completed · Phase 3
Conditions studied: HIV-1 Infection, HCV Infection
In brief
This study will evaluate efficacy of ledipasvir/sofosbuvir (LDV/SOF) and safety and tolerability of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) or emtricitabine/rilpivirine/tenofovir alafenamide (F/R/TAF) from the current antiretroviral (ARV) therapy and in virologically-suppressed, HIV-1/HCV co-infected participants.
Key facts
- Study ID
- NCT02707601
- Run by
- Gilead Sciences
- People needed
- 150
- Starts
- 2016-04-01
- Expected to finish
- 2017-09-29
- Last updated by the study team
- 2018-11-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- Spectrum Medical Group — Phoenix, Arizona, United States
- Mills Clinical Research — Los Angeles, California, United States
- Peter J Ruane MD Inc — Los Angeles, California, United States
- University of California Davis — Sacramento, California, United States
- University of California San Diego — San Diego, California, United States
- Kaiser Permanente — San Francisco, California, United States
- The George Washington University Medical Center — Washington D.C., District of Columbia, United States
- Whitman-Walker Health — Washington D.C., District of Columbia, United States
- Community AIDS Network — Clearwater, Florida, United States
- Gary Richmond, MD, PA, Inc. — Fort Lauderdale, Florida, United States
- Therafirst Medical Center — Fort Lauderdale, Florida, United States
- Midway Immunology & Research Center, LLC — Ft. Pierce, Florida, United States
- University of Miami — Miami, Florida, United States
- AIDS Healthcare Foundation — Miami, Florida, United States
- AIDS Healthcare Foundation — Miami Beach, Florida, United States
- Orlando Immunology Center — Orlando, Florida, United States
- St. Josephs Comprehensive Research Institute — Tampa, Florida, United States
- Triple O Research Institute PA — West Palm Beach, Florida, United States
- Rowan Tree Medical PA — Wilton Manors, Florida, United States
- AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
- Emory University — Atlanta, Georgia, United States
- Chatham County Health Department — Savannah, Georgia, United States
- The CORE Foundation — Chicago, Illinois, United States
- Be Well Medical Center — Berkley, Michigan, United States
Full record on ClinicalTrials.gov
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