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An expanded Phase I safety and drug absorption study of tenofovir gel used daily for seven consecutive days in women in their third trimester of pregnancy, and women who were breastfeeding. The study enrolled 90 pregnant women – 45 women at 37 weeks gestation and 45 women at 34 weeks gestation; and 16 women who were breastfeeding. MTN-008 was a follow-up study to MTN-002 and conducted at two U.S. sites. Results, presented in August 2013 and 2014, indicated that daily use of tenofovir gel in the third trimester of pregnancy was safe and well-tolerated, tenofovir did not accumulate in breast milk, and absorption of the drug in breastfeeding infants was low.



MTN-008 Backgrounder



MTN-008 Q&A



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See Also

MTN-008 Study Protocol