Back to top

MTN-007 was a Phase 1, randomized, blinded, placebo-controlled safety and acceptability study of tenofovir RG 1% gel when applied rectally. This study also examined whether rectal use of tenofovir RG 1% gel was associated with rectal mucosal damage using a broad range of immunological safety biomarkers. Nonoxynol-9 (N-9) 2% gel was used as a positive control for mucosal damage as rectal application of 2% N-9 was previously shown  to cause mild but transient mucosal damage. Other secondary objectives included evaluations of the acceptabilitSally Morrowy of rectal administration of tenofovir RG 1% gel as well as the safety of HEC placebo gel when applied rectally.

Recruitment began in late 2010 and ended in mid-2011 with 60 enrolled. Participants were randomized to receive a single dose of tenofovir RG 1% gel, 2% N-9 gel, placebo gel, or  no treatment, to be self-administered under observation. Within approximately 30 minutes, lavage, stool, and rectal biopsy specimens were collected. After a one-week recovery period, participants returned to the clinic for assessment. If no significant adverse events (AEs) were reported, participants began to self-administer once-daily doses of the study gel for 7 days on an outpatient basis. Participants returned to the clinic for evaluation and specimen collection after completion of 7 days of daily dosing. MTN-007 results were initially presented at the annual Conference on Retroviruses and opportunistic Infections (CROI) held on March 5-8, 2012 in Seattle, WA.

Protocol Chair(s)
Mayer, Kenneth (Protocol Co-Chair)
McGowan, Ian (Protocol Chair)
Protocol Title
A Phase 1 Randomized, Double-Blinded, Placebo-Controlled Rectal Safety and Acceptability Study of Tenofovir 1% Gel
DAIDS Protocol ID
10736
Status
Participants off Study and Primary Analysis Completed
Formulation
Gel
Drug
2% Nonoxynol‐9  
Placebo
Tenofovir   
Study Focus/Product Administration
Rectal
Study Type
Behavioral
Lab
Pharmacokinetics
Safety
Study Phase
Phase I  
Countries
United States
Population
Men (cisgender men, non‐transgender men)   
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
Other Study Info

Phase 1 randomized, double-blinded, multi-site, placebo-controlled trial