Assessing the Effect of Contraception and the Menstrual Cycle on Pharmacokinetics, Pharmacodynamics, and Vaginal Safety in Tenofovir Vaginal Gel Users

NCT01421368 Phase 1 COMPLETED

The purpose of the study is to examine the effects of two contraceptive methods and the menstrual cycle on the pharmacokinetics, pharmacodynamics of tenofovir 1% gel and the effect of the contraceptive methods on markers of mucosal safety.

Details

Lead sponsor	CONRAD
Phase	Phase 1
Status	COMPLETED
Enrolment	72
Start date	2012-03
Completion	2014-03

Conditions

• HIV Prevention

Interventions

• Tenofovir 1% vaginal gel
• Depo-medroxyprogesterone acetate (DMPA)
• Oral contraceptive: LNG 150 mcg and EE 30 mcg

Primary outcomes

• Effect of oral contraceptives and DMPA on tenofovir PK, PD, and safety by comparing the following endpoints before initiation of contraceptive method and 10 weeks after initiation of contraceptive method — 3 and 11 hours after insertion of 2 doses of study gel
  * composite of pharmacokinetics for TFV in plasma, vaginal aspirate \& genital tissue * composite of pharmacokinetics for TFV-DP in PBMCs, endocervical cells \& genital tissue * rates of HIV-1 infection in an explant challenge assay (one site only) * immune cell activation \& mucosal histology in genital tissue * genitourinary AEs

Countries

United States, Dominican Republic