MTN 017

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:Open label, Randomized
Arms and Assigned Interventions
DescriptionApplied rectally
Mode of DeliveryGel
ARMsExperimental
DescriptionDaily oral TDF/FTC
Mode of DeliveryTablet
ARMsExperimental
Results: MTN-017: A Rectal Phase 2 Extended Safety and Acceptability Study of Tenofovir Reduced-Glycerin 1% Gel
Official Code: NCT01687218
Related Publications:
MTN-017: Phase II Safety and Acceptability Study of Tenofovir Gel Reformulated for Rectal Use
Trial Sponsors: CONRAD, MTN, NIAID, NIMH
Start Date
End Date
September 30, 2013
May 4, 2015
Enrollment:186
Age range: 18 Years ↔ any
Population:Gay and Bisexual Men Who Have Sex with Men