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 accrual
Description
MTN-002 is the first study of a candidate topical microbicide in pregnant women. MTN-002 seeks 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 are looking at an antiretroviral-based candidate microbicide called tenofovir 1% gel, which will be applied as a one-time, single dose in 16 healthy HIV-negative women prior to giving birth by scheduled caesarean delivery. Researchers are conducting MTN-002 as a first step toward determining if use of a vaginal microbicide during pregnancy is safe for women and their babies.
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