MTN 008

Status:Completed
Phase:I
Principal Investigator(s):Richard Beigi
Objective:This study tested the safety of using tenofovir 1% gel in healthy, pregnant women and healthy, breastfeeding women.   Results: Daily TFV 1% vaginal gel use in term and near-term pregnancy appears to be safe and produces low serum drug levels.
Prevention Option(s):Microbicides
Study Design:Controlled, Double-blind, Randomized
Arms and Assigned Interventions
DescriptionWomen in their third trimester of pregnancy will receive tenofovir gel.
Mode of DeliveryGel
ARMsExperimental
DescriptionLactating mothers will receive tenofovir gel.
Mode of DeliveryGel
ARMsExperimental
Results: A randomized safety and pharmacokinetic trial of daily tenofovir 1% gel in term and near-term pregnancy.
Official Code: NCT01136759
Trial Sponsors: CONRAD, MTN, NIAID
Start Date
End Date
March 31, 2011
September 30, 2013
Enrollment:128
Age range: 18 Years ↔ 40 Years
Population:Cisgender Women