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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 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5399

Last updated 2026-05-05

Study results available
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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.

Conditions

  • Pre-Exposure Prophylaxis of HIV-1 Infection

Interventions

DRUG

F/TDF Placebo

Tablet administered orally once daily

DRUG

F/TAF Placebo

Tablet administered orally once daily

DRUG

F/TAF

200/25 mg tablet administered orally once daily

DRUG

F/TDF

200/300 mg tablet administered orally once daily

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-02
Primary Completion
2019-01-31
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Canada
  • Denmark
  • France
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02842086 on ClinicalTrials.gov