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
Closed to follow Up

Description

MTN-002 is the first study of a candidate topical microbicide in pregnant women. MTN-002 aimed to understand if and to what extent pregnancy affects how the body absorbs the active drug in a gel and whether the drug can be transferred to the fetus. Specifically, MTN-002 researchers studied an antiretroviral-based candidate microbicide called tenofovir 1% gel, which was applied as a one-time, single dose in 16 healthy HIV-negative women prior to giving birth by scheduled caesarean delivery. Researchers view MTN-002 as a first step toward determining if use of a vaginal microbicide during pregnancy is safe for women and their babies.  Results are expected in late May 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