Microbicide Trials Network

MTN-002

Details

Protocol Title: 
Phase I Study of the Maternal Single-Dose Pharmacokinetics and Placental Transfer of Tenofovir 1% Vaginal Gel among Healthy Term Gravidas
DAIDS Protocol ID: 
10600
Status: 
Participants off Study and Primary Analysis Completed

Protocol Chair(s)

Richard Beigi (Protocol Chair)

Description

MTN-002 was a Phase 1, single-site, open-label study of pharmacokinetic parameters and placental transfer of single-dose of tenofovir 1% gel when administered vaginally to 16 pregnant women at term who were scheduled for elective cesarean delivery.  Secondary objectives included the characterization of the systemic safety profile of single-dose tenofovir 1% gel in these women; a comparison of 3rd trimester absorption of tenofovir 1% gel to absorption in non-pregnant recent historic controls; and the assessment of amniotic fluid, cord blood, endometrial tissue and placental tissue levels following the observed administration of single-dose tenofovir 1% gel. This protocol was the first study of a candidate microbicide gel in pregnant women and represented an innovative approach to moving products into safety testing in pregnant women, a key recommendation of a 2008 Institute of Medicine report. 

 

This study served as the platform for planning and conducting additional studies of microbicide safety in pregnancy. Along with data derived from MTN-016 (Pregnancy Registry), it provides critical new information on the safety of vaginally applied products in pregnant women. MTN-002 results were first presented in 2010 during at the Microbicides 2010 Conference and at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) annual meeting in 2010.

Other Study Info

Sponsors:

Division of AIDS, US National Institute of Allergy and Infectious Diseases

US Eunice Kennedy Shriver National Institute of Child Health and Human Development

US National Institutes of Health

Co-Sponsor:

CONRAD

Study design:

Phase I, single-site, open label, pharmacokinetic (PK) and placental transfer evaluation