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MTN-002 was the first study of a candidate topical microbicide to be conducted in pregnant women, and importantly, served as both a platform and blueprint for ensuing studies of microbicide safety in pregnancy. MTN-002 sought to understand whether tenofovir gel, which was being evaluated in trials to support its potential licensure, would be safe to use during pregnancy. The Phase I study involved giving a single dose of tenofovir gel to 16 healthy, HIV-negative women hours before they gave birth by scheduled Cesarean section. Results, reported in 2010, found only small amounts of drug were absorbed into the mother’s bloodstream, amniotic fluid and umbilical cord (fetal) blood; and no serious side effects in either the mothers or their newborns. (See also MTN-008.)


Researchers report results of first microbicide trial in pregnant women

Study indicates small amount of drug passes to fetus



MTN-002 Backgrounder



MTN-002 Q&A



See Also

MTN-002 Protocol


MTN-002 Study Page


Trial is first to see if HIV prevention gels are safe for pregnant women & their babies