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Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection
Sponsor: Gilead Sciences
Summary
The primary objective of this study is to assess the rates of HIV-1 infection in Men (MSM) and transgender women (TGW) who have sex with men and who are administered daily emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir disoproxil fumarate (F/TDF) with a minimum follow-up of 48 weeks and at least 50% of participants have 96 weeks of follow-up after randomization.
Official title: A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
5399
Start Date
2016-09-02
Completion Date
2027-09
Last Updated
2025-11-13
Healthy Volunteers
Yes
Interventions
F/TAF
200/25 mg tablet administered orally once daily
F/TDF
200/300 mg tablet administered orally once daily
F/TAF Placebo
Tablet administered orally once daily
F/TDF Placebo
Tablet administered orally once daily
Locations (93)
Beverly Hills, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
Oakland, California, United States
Sacramento, California, United States
Sacramento, California, United States
San Diego, California, United States
San Francisco, California, United States
San Francisco, California, United States
San Francisco, California, United States
Torrance, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Washington D.C., District of Columbia, United States
Fort Lauderdale, Florida, United States
Fort Lauderdale, Florida, United States
Ft. Pierce, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Macon, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
Berkley, Michigan, United States
Detroit, Michigan, United States
Minneapolis, Minnesota, United States
Las Vegas, Nevada, United States
Somers Point, New Jersey, United States
Santa Fe, New Mexico, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
The Bronx, New York, United States
Chapel Hill, North Carolina, United States
Huntersville, North Carolina, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Austin, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Seattle, Washington, United States
Seattle, Washington, United States
Milwaukee, Wisconsin, United States
Graz, Austria
Vienna, Austria
Vancouver, British Columbia, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Hvidovre, Capital Region, Denmark
Aarhus N, Central Jutland, Denmark
Copenhagen, RegionH, Denmark
Odense, Denmark
Nice, Alpe Maritimes, France
Marseille, Provence-Alpes-Côte d'Azur Region, France
Paris, Provence-Alpes-Côte d'Azur Region, France
Paris, France
Munich, Bavaria, Germany
Berlin, Germany
Berlin, Germany
Frankfurt, Germany
Dublin, Dublin, Ireland
Dublin, Ireland
Milan, Italy
Roma, Italy
Amsterdam, Netherlands
Badalona, Barcelona, Spain
Barcelona, Spain
Madrid, Spain
Vigo, Spain
Soho, London, United Kingdom
Whitechapel, London, United Kingdom
Edinburgh, Scotland, United Kingdom
Brighton, Sussex, United Kingdom
Birmingham, United Kingdom
London, United Kingdom
London, United Kingdom
London, United Kingdom
London, United Kingdom
London, United Kingdom
Manchester, United Kingdom