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Safety and Effectiveness of TFV 1% Gel, TDF Tablets, and FTC/TDF Tablets in Preventing HIV in Women

NCT00705679 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5029

Last updated 2021-10-29

Study results available
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Summary

A new approach to HIV prevention currently being studied includes the use of microbicides, substances that kill microbes. Tenofovir disoproxil fumarate (TDF) and emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) are oral, FDA-approved, anti-HIV drugs, and tenofovir gel is an experimental microbicide. The purpose of this study is to determine the safety and effectiveness of daily tenofovir 1% gel compared to a vaginal placebo gel, and the safety and effectiveness of oral TDF and oral FTC/TDF compared to an oral placebo in preventing HIV infection among women at risk for sexually transmitted infections.

Conditions

  • HIV Infections

Interventions

DRUG

Emtricitabine/tenofovir disoproxil fumarate

200 mg/300 mg tablet

DRUG

Emtricitabine/tenofovir disoproxil fumarate placebo

placebo tablet

DRUG

Tenofovir disoproxil fumarate

300 mg tablet

DRUG

Tenofovir disoproxil fumarate placebo

placebo tablet

DRUG

Tenofovir 1% vaginal gel

1 gm/100 ml of 1% gel

DRUG

Tenofovir placebo

placebo gel

Sponsors & Collaborators

  • Microbicide Trials Network

    collaborator NETWORK

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Zvavahera M. Chirenje, MD, FRCOG · UZ-UCSF Collaborative Research Programme

  • Jeanne Marrazzo, MD, MPH · University of Washington, Division of Allergy and Infectious Disease

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • South Africa
  • Uganda
  • Zimbabwe

Study Locations

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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 NCT00705679 on ClinicalTrials.gov