MTN 011

Status:Completed
Phase:I
Principal Investigator(s):Beatrice A. Chen & Robert A. Salata
Objective:Aims to determine the effect that vaginal intercourse may have on drug absorption and drug activity of different dosing strategies of tenofovir gel.   Results: Timing of TFV gel application relative to sex significantly impacts drug levels. BAT dosing or sustained delivery may be optimal for preexposure prophylaxis
Prevention Option(s):Microbicides
Study Design:Non-randomized, Open label
Arms and Assigned Interventions
Description1% tenofovir gel used around the time of vaginal intercourse.
Mode of DeliveryGel
ARMsExperimental
Description1% tenofovir gel used daily.
Mode of DeliveryGel
ARMs
Results: Impact of Sex on the Pharmacokinetics and Pharmacodynamics of 1% Tenofovir Gel
Official Code: NCT01687205
Trial Sponsors: CONRAD, MTN, NIAID, NIMH
Start Date
End Date
November 30, 2012
April 30, 2015
Enrollment:62
Age range: 21 Years ↔ 46 Years
Population:Cisgender Men, Cisgender Women