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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.

 

ResultsDaily 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
Randomized
Double-blind
Arms and Assigned Interventions
Description
Women in their third trimester of pregnancy will receive tenofovir gel.
Mode of Delivery
Gel
Products
1% tenofovir gel
ARMs
Experimental
Description
Lactating mothers will receive tenofovir gel.
Mode of Delivery
Gel
Products
1% tenofovir gel
ARMs
Experimental
Description
Women in their third trimester of pregnancy will receive placebo gel.
Mode of Delivery
Gel
ARMs
Placebo Comparator
Trial Sponsors
NIAID, CONRAD, MTN
March 2011
September 2013
Enrollment
128
18
Years
40
Years
Population
Women
Sites

Alabama Microbicide CRS

Birmingham, Alabama
United States of America

University of Pittsburgh CRS

Pittsburgh, Pennsylvania
United States of America