MTN-002
- 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
- Open to accrual
- A study involving 16 pregnant women that will look at the absorption and drug activity of a single dose of tenofovir topical gel, an antiretroviral-based candidate microbicide, given prior to caesarean delivery. The study is expected to start in the fall of 2007 at the University of Pittsburgh. MTN-002 is the first trial of a candidate microbicide in pregnant women, which seeks to understand the extent of drug absorption during pregnancy and the degree to which the gel’s active ingredient may be transferred to the fetus.