Switch Study to Evaluate F/TAF in HIV-1 Positive Participants Who Are Virologically Suppressed on Regimens Containing FTC/TDF

Completed · Phase 3 · Has a placebo group

Conditions studied: HIV-1 Infection

In brief

This study will evaluate the efficacy of switching from emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) fixed dose combination (FDC) to emtricitabine/tenofovir alafenamide (F/TAF) FDC in HIV-1 positive participants who are virologically suppressed on regimens containing FTC/TDF. This study will consist of a 96 week double-blind treatment period. After Week 96, all participants will continue on blinded study drug treatment and attend visits every 12 weeks until treatment assignments are unblinded. All participants will return for an unblinding visit and will be given the option to receive open-label F/TAF and attend visits every 12 weeks until F/TAF is commercially available, or the sponsor terminates the F/TAF clinical development program.

Key facts

Study ID

NCT02121795

Run by

Gilead Sciences

People needed

668

Starts

2014-05-06

Expected to finish

2019-03-01

Last updated by the study team

2020-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Spectrum Medical Group — Phoenix, Arizona, United States
• Pacific Oaks Medical Group — Beverly Hills, California, United States
• Kaiser Permanente — Hayward, California, United States
• Tarrant County ID Associates — Los Angeles, California, United States
• Southern California Men's Medical Group — Los Angeles, California, United States
• Highland Hospital - Alameda Health System (formerly Alameda County medical Center) — Oakland, California, United States
• Kaiser Permanente Sacramento Medical Center — Sacramento, California, United States
• La Playa Medical Group and Clinical Research — San Diego, California, United States
• Kaiser Permanente Medical Group San Francisco — San Francisco, California, United States
• Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center — Torrance, California, United States
• Kaiser Permanente Colorado — Denver, Colorado, United States
• National Jewish Health — Denver, Colorado, United States
• Apex Research LLC — Denver, Colorado, United States
• Dupont Circle Physician's Group — Washington D.C., District of Columbia, United States
• Whitman-Walker Health — Washington D.C., District of Columbia, United States
• Capital Medical Associates — Washington D.C., District of Columbia, United States
• Medical Faculty Associates — Washington D.C., District of Columbia, United States
• TheraFirst Medical Center — Fort Lauderdale, Florida, United States
• Gary J. Richmond,M.D.,P.A. — Fort Lauderdale, Florida, United States
• Midway Immunology and Research Center — Ft. Pierce, Florida, United States
• Tarrant County Infectious Disease Associates — Miami, Florida, United States
• AIDS Healthcare Foundation — Miami Beach, Florida, United States
• Orlando Immunology Center — Orlando, Florida, United States
• AIDS Healthcare Foundation — Tampa, Florida, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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