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Evaluating the Safety of Tenofovir Vaginal Gel in HIV-Uninfected Pregnant Women

NCT01490671 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-11-01

No results posted yet for this study

Summary

Preliminary research has shown that a vaginal gel containing the antiretroviral (ARV) drug tenofovir may reduce the risk of HIV infection in women when used near the time of sexual intercourse. This study will evaluate the safety of 1% tenofovir gel in HIV-uninfected pregnant women and their newborns when the gel is used once a day for a period of 28 days at a designated time during pregnancy.

Conditions

  • HIV Infections

Interventions

DRUG

1% tenofovir gel

One applicator of 1% tenofovir gel will be inserted by the participant into the vagina once each day for 28 days or until delivery, whichever comes first

DRUG

Placebo gel

One applicator of placebo gel will be inserted by the participant into the vagina once each day for 28 days or until delivery, whichever comes first

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Richard H Beigi, MD, MSc · University of Pittsburgh

  • Bonus Makanani, MBBS, FCOG (SA) · Kamuzu University of Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Primary Completion
2015-08-31

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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 NCT01490671 on ClinicalTrials.gov