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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

NCT02842086

TerminatedPhase 3

Sponsor: Gilead Sciences

Conditions: Pre-Exposure Prophylaxis of HIV-1 Infection

Interventions: F/TAF, F/TDF, F/TAF Placebo, F/TDF Placebo

Countries: United States, Austria, Canada, Denmark, France, Germany, Ireland, Italy

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Key Inclusion Criteria:

* Must be at high risk of sexual acquisition of HIV
* HIV-1 negative status
* MSM and TGW (male at birth) who have at least one of the following:

  * condomless anal intercourse with at least two unique male partners in the past 12 weeks (partners must be either HIV-infected or of unknown HIV status)
  * documented history of syphilis in the past 24 weeks
  * documented history of rectal gonorrhea or chlamydia in the past 24 weeks
* Adequate renal function: estimated glomerular filtration rate ≥ 60 mL/min according to the Cockcroft-Gault formula
* Adequate liver and hematologic function:

  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN) and total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
  * Absolute neutrophil count ≥ 1000/mm\^3; platelets ≥ 75,000/mm\^3; hemoglobin ≥ 10 g/dL

Key Exclusion Criteria

* Grade 3 or Grade 4 proteinuria or glycosuria that is unexplained or not clinically manageable.

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

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
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