Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants
Completed · Phase 3
Conditions studied: HIV, HIV Infections
In brief
The primary objective of this study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected participants as determined by having HIV-1 RNA \< 50 copies/mL at Week 48.
Key facts
- Study ID
- NCT01815736
- Run by
- Gilead Sciences
- People needed
- 1443
- Starts
- 2013-03-27
- Expected to finish
- 2020-04-01
- Last updated by the study team
- 2021-04-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Southwest Center for HIV/AIDS — Phoenix, Arizona, United States
- Spectrum Medical Group — Phoenix, Arizona, United States
- Health for Life Clinic PLLC — Little Rock, Arkansas, United States
- AHF Research Center — Beverly Hills, California, United States
- Michael Keith Wensley, MD, Inc., A Medical Corporation — Costa Mesa, California, United States
- Living Hope Clinical Foundation — Long Beach, California, United States
- Kaiser Permanente — Los Angeles, California, United States
- Jeffrey Goodman Special Care Clinic — Los Angeles, California, United States
- Peter J Ruane, MD, Inc — Los Angeles, California, United States
- Anthony Mills MD Inc — Los Angeles, California, United States
- Orange Coast Medical Group — Newport Beach, California, United States
- Alameda County Medical Center — Oakland, California, United States
- East Bay AIDS Center — Oakland, California, United States
- Stanford University — Palo Alto, California, United States
- University of California, Davis Medical Center — Sacramento, California, United States
- Kaiser Permanente Medical Group — Sacramento, California, United States
- La Playa Medical Group and Clinical Research — San Diego, California, United States
- Metropolis Medical Group — San Francisco, California, United States
- Kaiser Permanente Medical Center, Clinical Trials Unit — San Francisco, California, United States
- Kaiser Permanente Hospital — San Leandro, California, United States
- Apex Research LLC — Denver, Colorado, United States
- Greenwich Hospital — Greenwich, Connecticut, United States
- Yale University HIV Clinical Trials Program — New Haven, Connecticut, United States
- Dupont Circle Physicians Group — Washington D.C., District of Columbia, United States
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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