Microbicide Trials Network

MTN-008

Details

Protocol Title: 
Expanded Safety of Tenofovir 1% Gel in Pregnancy and Lactation
DAIDS Protocol ID: 
10805
Status: 
Participants off Study and Primary Analysis Completed

Protocol Chair(s)

Richard Beigi (Protocol Chair)

Description

MTN-008 was the first study of repeat dosing of tenofovir 1% gel in pregnant and lactating women.  Consistent with recommendations of the Institute of Medicine, the MTN-008 mother-infant pair study pursued critically valuable safety and PK data for microbicide use in HIV-uninfected women during pregnancy and breastfeeding. The protocol also assessed the presence of tenofovir in the blood of infants of women who enrolled in the Pregnancy and Lactation Cohorts, and examined the impact of tenofovir 1% gel exposure on the presence of select organisms in the vagina.  This study provided novel safety data on tenofovir 1% gel use among pregnant and lactating women, who represent a uniquely susceptible population of women in terms of HIV acquisition risk. Follow-up for all participants completed in 2013. Primary manuscripts are in progress.

Other Study Info

Sponsors:

DAIDS/NIAID/NIH

US National Institute of Child Health and Human Development

Study Product Provided by: CONRAD