1Magee-Womens Hospital of the University of Pittsburgh Medical Center2Microbicide Trials Network, Magee-Womens Research Institute, Pittsburgh, Pennsylvania3Department of Medicine (Clinical Pharmacology), Johns Hopkins University School of Medicine4John's Hopkins University School of Public Health, Baltimore5National Institute of Allergy and Infectious Diseases, Division of AIDS, National Institutes of Health6Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland7Statistical Center for HIV/AIDS15 Research and Prevention (SCHARP), Fred Hutchinson Cancer Research Center, Seattle, Washington8FHI, Research Triangle Park, North Carolina9CHU-Sainte Justine Research Center, Université de Montréal, Québec, Canada
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Tenofovir (TFV) 1% vaginal gel has been found to decrease sexual transmission of human immunodeficiency virus. To initiate investigations during pregnancy, 16 healthy pregnant women scheduled for cesarean delivery received a single application of TFV gel preoperatively. Maternal serum drug concentrations were determined and fetal cord blood, amniotic fluid, placental tissue, and endometrial tissue specimens were collected. The median maternal peak concentration and cord blood TFV concentrations were 4.3 and 1.9 ng/mL, respectively (∼100- and 40-fold lower than after TFV oral dosing, respectively). No adverse events were related to the use of TFV gel. These findings support ongoing and future investigations of TFV gel in pregnancy.Clinical Trial Registration: NCT00572273. http://www.clinicaltrials.gov/ct2/show/NCT00540605?term=mtn-002&rank=1.