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Emtricitabine/Tenofovir Disoproxil Fumarate for HIV Prevention in Men

NCT00458393 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2499

Last updated 2021-11-02

Study results available
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Summary

The purpose of this study is to determine whether daily use of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) can prevent HIV infection in men who also receive HIV counseling, condoms, and treatment for other sexually transmitted infections (STIs).

Conditions

  • HIV Infections

Interventions

DRUG

daily TDF/FTC

daily oral medication

DRUG

Placebo

daily oral medication

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Robert M. Grant, MD, MPH · J. David Gladstone Institutes, University of California San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States
  • Brazil
  • Ecuador
  • Peru
  • South Africa
  • Thailand

Study Locations

More Related Trials

Entities

Drugs

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 NCT00458393 on ClinicalTrials.gov