Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Adults on Chronic Hemodialysis
Completed · Phase 3
Conditions studied: HIV-1 Infection
In brief
The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV-1) infected adults with end-stage renal disease (ESRD) on chronic hemodialysis (HD).
Key facts
- Study ID
- NCT02600819
- Run by
- Gilead Sciences
- People needed
- 55
- Starts
- 2015-12-14
- Expected to finish
- 2019-10-15
- Last updated by the study team
- 2020-11-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Peter J Ruane MD Inc — Los Angeles, California, United States
- University of California Davis — Sacramento, California, United States
- Midway Immunology & Research Center, LLC — Ft. Pierce, Florida, United States
- Infectious Disease Consultants, M.D., P.A. d/b/a Orlando Immunology Center — Orlando, Florida, United States
- Triple O Research Institute PA — West Palm Beach, Florida, United States
- Medical College of Georgia — Augusta, Georgia, United States
- Infectious Disease Specialists of Atlanta — Decatur, Georgia, United States
- Mercer University School of Medicine — Macon, Georgia, United States
- The Research Institute — Springfield, Massachusetts, United States
- Henry Ford Health System — Detroit, Michigan, United States
- Prime Health Care Services - St Michael's LLC d/b/a Saint Michael's Medical Center — Newark, New Jersey, United States
- University of North Carolina at Chapel Hill / UNC School of Medicine — Chapel Hill, North Carolina, United States
- Duke University — Durham, North Carolina, United States
- Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States
- University of Cincinnati Med Center — Cincinnati, Ohio, United States
- MetroHealth Medical Center IRB — Cleveland, Ohio, United States
- North Texas Infectious Diseases Consultants — Dallas, Texas, United States
- Trinity Health and Wellness Center — Fort Worth, Texas, United States
- Gordon E. Crofoot MD PA — Houston, Texas, United States
- Otto Wagner Spital — Vienna, Austria
- Hopital Henri Mondor — Créteil, France
- CHU de Nice-l Archet — Nice, France
- Hopital Bichat-Claude Bernard — Paris, France
- Hopital Saint Louis — Paris, France
- Centre Hospitalier de Tourcoing — Tourcoing, France
Full record on ClinicalTrials.gov
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