CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 195 enrolled
Drug / intervention
Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet) +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01687218
NCT01687218Phase 2Completed

A Phase 2 Randomized Sequence Open Label Expanded Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel

CONRAD·interventional·Posted Sep 18, 2012·Updated Jun 24, 2021

In Brief

A Phase 2 clinical trial evaluating Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet), Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel), and 1 other intervention for HIV. Completed, enrolled 195 participants across 8 sites in 5 countries.

Detailed Summary

MTN-017 is a Phase 2, multi-site, randomized, six-sequence, two three-period, open label crossover study, examining the effects of oral Truvada and reduced glycerin 1% tenofovir gel. The study population will be sexually active, HIV-uninfected males who are 18 years of age or older, who report a history of receptive anal intercourse in the past 3 months. Each of the study product regimens offers different advantages to participants seeking an effective HIV prevention agent. How these relative advantages will compare in terms of safety, acceptability, systemic and local absorption, and adherence will be examined within this study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesPeru, Puerto Rico, South Africa, Thailand, United States

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 18, 2012
Enrollment StartSep 25, 2013
Primary CompletionMay 26, 2015
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.8 years ago

Interventions

Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)drug

Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)drug

Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)drug