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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®

Protocol Chair(s)
Cranston, Ross (Protocol Chair)
Lama, Javier (Protocol Co-Chair)
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
Formulation
Gel
Oral Tablet
Drug
Tenofovir   
Truvada® (emtricitabine +tenofovir disoproxil fumarate)
Study Focus/Product Administration
Oral
Rectal
Study Type
Behavioral
Pharmacokinetics
Safety
Study Phase
Phase II
Countries
Peru
South Africa
Thailand
United States
Population
Men (cisgender men, non‐transgender men)   
Transgender women
Funder(s)
Division of AIDS, US National Institute of Allergy and Infectious Diseases
US National Institute of Mental Health
US National Institutes of Health
Sponsor(s)
CONRAD
Gilead Sciences, Inc.