MTN 002
Status:Completed
Phase:I
Principal Investigator(s):Richard Beigi
Objective:To determine the levels of tenofovir, a microbicide in gel form, in HIV uninfected pregnant women who are expecting to deliver by cesarean
Results: 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.
Prevention Option(s):Microbicides
Study Design:Open label, Randomized, Uncontrolled
Arms and Assigned Interventions
Description4g tenofovir 1% gel applied vaginally 2 hours prior to expected time of cesarean delivery
Mode of DeliveryGel
ARMsExperimental
Results: Pharmacokinetics and placental transfer of single-dose tenofovir 1% vaginal gel in term pregnancy
Official Code:
NCT00540605
Trial Sponsors:
CONRAD, MTN, NIAID, NICHD
Start Date
End Date
none
January 31, 2010
Enrollment:16
Age range:
18 Years ↔
45 Years
Population:Cisgender Women