MTN-002

Primary Objective

• Assess term pregnancy maternal single-dose pharmacokinetics of tenofovir 1% vaginal gel

Study Summary
MTN-002 was a Phase 1, single-site, open-label study of pharmacokinetic parameters and placental transfer of single-dose of tenofovir 1% gel when administered vaginally to 16 pregnant women at term who were scheduled for elective cesarean delivery. Secondary objectives included the characterization of the systemic safety profile of single-dose tenofovir 1% gel in these women; a comparison of 3rd trimester absorption of tenofovir 1% gel to absorption in non-pregnant recent historic controls; and the assessment of amniotic fluid, cord blood, endometrial tissue and placental tissue levels following the observed administration of single-dose tenofovir 1% gel. This protocol was the first study of a candidate microbicide gel in pregnant women and represented an innovative approach to moving products into safety testing in pregnant women, a key recommendation of a 2008 Institute of Medicine (IOM) report. This study served as the platform for planning and conducting additional studies of microbicide safety in pregnancy. Along with data derived from MTN-016 (HIV Prevention Agent Pregnancy Exposure Registry), it provided critical new information on the safety of vaginally applied products in pregnant women.

MTN-002 completed follow-up on January 5, 2010. Results were first presented in 2010 at the Microbicides 2010 Conference held on May 22-25, 2010, in Pittsburgh, PA and at the 2010 Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meeting held on August 5-7 in Santa Fe, New Mexico. The primary manuscript, the only paper from this study, was published online in the Journal of Infectious Diseases in September 2011.

Primary Results
No significant safety concerns were identified. Tenofovir was generally detectable at low levels in maternal and cord blood. In maternal plasma the median C_max after this single dose application of gel was approximately 100-fold lower than the C_max noted after a maternal dose of 600 mg oral TFV used for the prevention of mother-to-child transmission. These findings support ongoing and future investigations of TFV gel in pregnancy.