LAST UPDATED
May 05, 2026
Clinicaltrials.gov ID
CTSID
EudraCT ID
OVERVIEW
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 (DISCOVER)
PROTOCOL 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.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
true
Age
18 years +
Sex
All
Healthy Volunteers
true
Study details
Medical Condition
Pre-Exposure Prophylaxis of HIV-1 Infection
Gender
Men and Transgender Women
Date
September 2016 - January 2019
Study Type
Interventional
Study Phase
Phase 3
Product
F/TAF, F/TDF, F/TAF Placebo, F/TDF Placebo
Eligibility information
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
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.
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