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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
Uncontrolled
Randomized
Open label
Arms and Assigned Interventions
Description
4g tenofovir 1% gel applied vaginally 2 hours prior to expected time of cesarean delivery
Mode of Delivery
Gel
Products
1% tenofovir gel
ARMs
Experimental
Trial Sponsors
NIAID, NICHD, MTN, CONRAD
January 2010
Enrollment
16
18
Years
45
Years
Population
Women
Sites

Pitt CRS

Pittsburgh, Pennsylvania
United States of America