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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
Description
1% tenofovir gel used around the time of vaginal intercourse.
Mode of Delivery
Gel
Products
1% tenofovir gel
ARMs
Experimental
Description
1% tenofovir gel used daily.
Mode of Delivery
Gel
Products
1% tenofovir gel
Trial Sponsors
CONRAD, MTN, NIAID, NIMH
November 2012
April 2015
Enrollment
62
21
Years
46
Years
Population
Women
Men
Sites

Case Western Reserve University

Cleveland, Ohio
United States of America

Magee Women's Hospital of UPMC

Pittsburgh
United States of America