title: Pharmacokinetics and placental transfer of single-dose tenofovir 1% vaginal gel in term pregnancy.
abstract: 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.
  
  
  BACKGROUND
  NCT00572273. http://www.clinicaltrials.gov/ct2/show/NCT00540605?term=mtn-002&rank=1.
authors.affiliation: Magee-Womens Hospital of the University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Beigi
authors.forename: Lisa
authors.initials: L
authors.lastname: Noguchi
authors.forename: Teresa
authors.initials: T
authors.lastname: Parsons
authors.forename: Ingrid
authors.initials: I
authors.lastname: Macio
authors.forename: Ratiya P
authors.initials: RP
authors.lastname: Kunjara Na Ayudhya
authors.forename: Jianmeng
authors.initials: J
authors.lastname: Chen
authors.forename: Craig W
authors.initials: CW
authors.lastname: Hendrix
authors.forename: Benoît
authors.initials: B
authors.lastname: Mâsse
authors.forename: Megan
authors.initials: M
authors.lastname: Valentine
authors.forename: Jeanna
authors.initials: J
authors.lastname: Piper
authors.forename: D Heather
authors.initials: DH
authors.lastname: Watts
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics; D000328:Adult; D000653:Amniotic Fluid / Q000737:chemistry; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D002585:Cesarean Section; D004717:Endometrium / Q000737:chemistry; D005260:Female; D005312:Fetal Blood / Q000737:chemistry*; D006801:Humans; D008431:Maternal-Fetal Exchange; D063065:Organophosphonates / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D010920:Placenta / Q000737:chemistry / Q000378:metabolism*; D011247:Pregnancy; D000068698:Tenofovir; D014622:Vaginal Creams, Foams, and Jellies / Q000008:administration & dosage
chemical_list: D019380:Anti-HIV Agents; D063065:Organophosphonates; D014622:Vaginal Creams, Foams, and Jellies; D000068698:Tenofovir; D000225:Adenine