MTN-008

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. Results for the Lactation Cohort were first presented at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) 2013. Results for the Pregnancy Cohort were first presented at IDSOG 2014. The two primary manuscripts were published in Antimicrobial Agents and Chemotherapy on August 22, 2016 and in Journal of the International AIDS Society on September 21, 2016 respectively.

Protocol Chair(s)
Beigi, Richard (Protocol Chair)
Protocol Title
Expanded Safety Investigation of Tenofovir 1% Gel in Pregnancy and Lactation
DAIDS Protocol ID
10805
Status
Concluded
Formulation
Gel
Drug
Placebo
Tenofovir   
Study Focus/Product Administration
Vaginal
Study Type
Behavioral
Pharmacokinetics
Safety
Study Phase
Phase I  
Countries
United States
Population
Infants
Lactating  
Pregnant  
Women (cisgender women, non‐transgender women)
Funder(s)
DAIDS/NIAID/NIH
US National Institute of Child Health and Human Development
Sponsor(s)
CONRAD
Email Groups

Source URL: https://mtnstopshiv.org/research/studies/mtn-008