Microbicide Trials Network

MTN-017

Details

Protocol Title: 
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.
DAIDS Protocol ID: 
11857
Status: 
Participants off Study and Primary Analysis Completed

Protocol Chair(s)

Ross Cranston (Protocol Chair)
Javier Lama (Protocol Co-Chair)

Description

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  (as shown in the table below). The study enrolled 195 sexually active, HIV-uninfected males or transgender females at least 18 years of age who also report a history of RAI in the past 3 months. Participants were randomized equally across the 6 sequences and followed for approximately 27 weeks (>6 months). Study product use periods included three 8-week sessions with 1-week washout periods between each. One week following the third 8-week session, a follow-up visit occurs. To assess acceptability, participants self-reported ease of use, liking the product, and likelihood of product use if shown to be effective. Each of the study product regimens offers different advantages to participants seeking an effective HIV prevention agent. How these relative advantages compare in terms of safety, acceptability, systemic and local absorption, and adherence is being examined within this study.

 

Sequence

Period 1

(8 weeks)

Washout

(>1 week)

Period 2

(8 weeks)

Washout

(>1 week)

Period 3

(8 weeks)

1

 Daily Truvada®

 

 Daily tenofovir RG 1% gel

 

 RAI-associated tenofovir RG 1% gel

2

 RAI-associated tenofovir RG 1% gel

 

 Daily Truvada®

 

 Daily tenofovir RG 1% gel

3

 Daily tenofovir RG 1% gel

 

 RAI-associated tenofovir RG 1% gel

 

 Daily Truvada®

4

 Daily  tenofovir RG 1% gel

 

 Daily Truvada®

 

 RAI-associated tenofovir RG 1% gel

5

 Daily Truvada®

 

 RAI-associated tenofovir RG 1% gel

 

 Daily tenofovir RG 1% gel

6

 RAI-associated tenofovir  RG 1% gel

 

 Daily tenofovir RG 1% gel

 

 Daily Truvada®

Other Study Info

Funding Agencies:

Division of AIDS, US National Institute of Allergy and Infectious Diseases

US National Institute of Mental Health

US National Institutes of Health 

IND Sponsor:

CONRAD

Pharmaceutical Company Collaborator:

Gilead Sciences, Inc.