Study Details - Gilead Clinical Trials

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.

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

true

Medical Condition

Pre-Exposure Prophylaxis of HIV-1 Infection

Gender

Men and Transgender Women

Date

September 2016 - January 2019

Study Type

INTERVENTIONAL

Study Phase

PHASE3

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.