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Interventional Study of Mucosal and Antimicrobial Responses to Repeated Vaginal Applications of Tenofovir Gel in HIV Uninfected Women

NCT00594373 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-11-01

No results posted yet for this study

Summary

Topical microbicides, substances that kill microbes, are being studied to prevent sexual transmission of HIV and other disease-causing agents. In the future, topical microbicides may be applied vaginally to prevent both acquisition and transmission of HIV and other sexually transmitted infections (STIs). The purpose of this study is to assess whether there is a measurable response to daily applications of a topical microbicide, 1% tenofovir gel, in women at low risk for HIV infection.

Conditions

  • HIV Infections

Interventions

DRUG

Tenofovir gel

1 gm/100 ml of 1% tenofovir gel vaginally daily

DRUG

Tenofovir gel placebo

1 gm/100 ml of placebo gel vaginally daily

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Marla Keller, MD · Albert Einstein College of Medicine

  • Betsy Herold, MD · Albert Einstein College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Primary Completion
2009-11-30
Completion
2010-04-30

Countries

  • United States

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 NCT00594373 on ClinicalTrials.gov