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Safety and Acceptability of a Vaginal Microbicide

NCT00111943 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-11-01

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and acceptability of a vaginal microbicide in HIV uninfected sexually active women.

Study hypothesis: The vaginal microbicide 1% tenofovir will be safe and well tolerated in HIV uninfected women who are in good general health.

Conditions

  • HIV Infections
  • Hepatitis B, Chronic

Interventions

DRUG

1% tenofovir gel

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Sharon Hillier, PhD · Department of Obstetrics and Gynecology and Reproductive Sciences, Magee-Women's Hospital

  • Jessica Justman, MD · Bronx-Lebanon Hospital Center

  • Smita N. Joshi, MBBS · National AIDS Research Institute (NARI)

  • Craig Hoesley, MD · University of Alabama at Birmingham

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

Completion
2007-10-31

Countries

  • United States
  • India

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 NCT00111943 on ClinicalTrials.gov