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