Tenofovir Gel in Pregnancy and Lactation

ClinicalTrials.gov ID: NCT01136759

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Official title

Expanded Safety Investigation of Tenofovir 1% Gel in Pregnancy and Lactation

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Tenofovir 1% gel is an investigational vaginal microbicide intended to reduce the risk of transmission of HIV. Pregnant women and mothers who have recently given birth often maintain sexual activity, and research has shown that they may be at greater risk of HIV infection during pregnancy. Microbicides may be able to prevent HIV infection during pregnancy, which would also prevent fetal exposure to HIV. This study will test the safety of using tenofovir 1% gel in healthy, pregnant women and healthy, breastfeeding women.

Study identification

NCT ID: NCT01136759
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID); NIH
Enrollment: 232 participants

Conditions and interventions

Conditions

HIV Infections

Interventions

Tenofovir 1% gel Drug
Placebo gel Other

Drug · Other

Eligibility (public fields only)

Age range: 18 Years to 40 Years
Sex: Female
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 2011 (Type not available)
Primary completion: Sep 2013 (Actual)
Completion: Sep 2013 (Actual)
Last update posted: Oct 25, 2021

2011 – 2013

United States locations

U.S. sites: 2
U.S. states: 2
U.S. cities: 2

Facility	City	State	ZIP	Site status
Alabama CRS	Birmingham	Alabama	35294	—
University of Pittsburgh CRS	Pittsburgh	Pennsylvania	15213-2582	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01136759, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 25, 2021 · Synced Nov 14, 2026