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Status
Completed
Phase
II
Principal Investigator(s)
Ross Cranston
Objective
MTN-017 is a Phase 2, multi-site, six-sequence, three-period, open label, crossover, randomized study examining the effects of oral FTC/TDF (Truvada®) and tenofovir RG 1% gel used as a rectal microbicide.
Results: Rectal application of RG TFV gel was safe in MSM and TGW. Adherence and product use likelihood were similar for the intermittent gel and daily oral FTC/TDF regimes, but lower for the daily gel regimen.
Prevention Option(s)
Microbicides
PrEP
Study Design
Randomized
Open label
Arms and Assigned Interventions
Description
Applied rectally
Mode of Delivery
Gel
Products
Reduced Glycerin 1% Tenofovir Gel
ARMs
Experimental
Description
Daily oral TDF/FTC
Mode of Delivery
Tablet
Products
TDF/FTC (Truvada)
ARMs
Experimental
Official Code
Related Publications
Trial Sponsors
CONRAD, MTN, NIAID, NIMH
Product Developers
Gilead, CONRAD
September 2013
May 2015
Enrollment
186
18
Years
Population
MSM
Sites
Chiang Mai University
Chiang Mai
Thailand
Desmond Tutu Clinical Research Center
Cape Town, South Africa
South Africa
Fenway Community Health Clinical Research Site (FCHCRS)
Boston, Massachusetts
United States of America
Pittsburg Clinical Research Site
Pittsburg, Pennsylvania
United States of America
Puerto Rico CEMI Clinical Research Site
San Juan
Puerto Rico
San Francisco Clinical Research Site
San Francisco, California
United States of America
San Miguel Clinical Research Site
Lima
Peru
Silom Community Clinic
Bangkok
Thailand