Rectal Microbicide Gel Study Launching Soon
Rectal microbicides—anti-HIV gels, creams, or other products that can be applied rectally before anal sex—are in development as another HIV prevention option for both men and women. Rectal microbicides have the benefit of putting antiretroviral agents “in the right place at the right time”—that is, on rectal tissue during sex, when HIV may be introduced into the body.
Advocates are looking ahead to January 2013, when a new study is slated to begin testing the safety and acceptability of a rectal microbicide gel containing the antiretroviral drug tenofovir. The MTN-017 trial is evaluating a tenofovir gel specifically reformatted for rectal rather than vaginal use. It will enroll 186 men who have sex with men and transgender women at research sites in Peru, South Africa, Thailand, and the United States.
This will be a Phase II trial, which means it builds on safety and acceptability data from a previous, smaller study. The goal of this more advanced trial is to further test the product’s safety for rectal use and get feedback on its acceptability—that is, how well people liked using it during the trial, and how likely they would be to use it again if it were approved as a new HIV prevention tool.
Results from this trial will determine whether the product should be studied in larger groups of people to further assess its safety and evaluate its efficacy—that is, whether or not the product actually has HIV prevention benefits.
To learn more about rectal microbicide research and the MTN-017 trial in particular, check out these online resources:
- “The Rectal Revolution Is Here: An Introduction to Rectal Microbicide Clinical Trials”
This engaging and informative video, produced by International Rectal Microbicide Advocates (IRMA), the Population Council, and the Microbicide Trials Network (MTN), aims to educate HIV-affected communities about rectal microbicide research and show how individuals can make a difference by taking part in clinical trials of new HIV prevention options.
- AIDS 2012: Meet Rig
In this BETA Q&A, Rig Rush, a trial volunteer featured in the “Rectal Revolution” video listed above and a panelist at the 2012 International AIDS Conference, speaks candidly about his experience in a rectal microbicide trial and offers advice young gay men can use to make healthy decisions around sex.
- MTN-017 backgrounder
The Microbicide Trials Network provides this reader-friendly guide to the upcoming study, explaining why the tenofovir gel is being developed for HIV prevention and how the trial is designed (and why it’s so important).
- Official study listing on ClinicalTrials.gov
Although the trial is listed as “not yet recruiting,” the description at ClinicalTrials.gov offers a wealth of information about the upcoming study’s goals, structure, and procedures, as well as eligibility criteria for joining the trial, where study sites are located, and how to volunteer.
Reilly O’Neal is a freelance writer and former editor of BETA.