One of the first rectal safety studies of a microbicide set to launch at Fenway in early 2010
The news out of Thailand in September 2009 regarding progress in HIV vaccine development has provided a desperately needed boost to the field of HIV prevention. The news from Thailand arrives just as a recent success has been reported in the microbicide field.
In February 2009, it was reported that one of the leading vaginal microbicide candidates, Pro 2000, had a limited protective effect. When viewed in tandem, these two successes are poised to energize the entire field, which includes not only vaccines but also vaginal and rectal microbicides and oral prophylaxis (PEP and PrEP).
As microbicide research moves forward, additional data needs to be collected looking at safety, acceptability and efficacy. The Microbicide Trials Network (MTN) is leading this research with a series of studies. One of these studies, MTN-007, is set to launch at Fenway Health in the spring of 2010.
MTN-007 is a Phase I, randomized, blinded, placebo-controlled safety and acceptability study of tenofovir 1% gel when applied rectally. Participants will be randomized to receive a single dose of tenofovir 1% gel, 2% N-9 gel or a placebo gel that is applied by a clinician at the study site. Participants will return to the clinic one week later, where they will be given a 7-day supply of the study gel. The study will enroll approximately 63 men and women at three sites in the United States including University of Pittsburgh, University of Alabama Birmingham and Fenway Health.
Dr. Kenneth Mayer, Principal Investigator and Medical Research Director of The Fenway Institute, is leading the effort here. Dr. Mayer has been a leader in microbicide research and has co-authored several articles examining the safety and acceptability of microbicides.
“Knowing rectal safety of a microbicide is very important. If current trials show vaginal efficacy, men and women will most likely start using the product rectally. We need to know if it will be safe to do so. If these products go on the market, education and counseling will be required around their proper use and any potential risks around misuse. MTN-007 will give us invaluable safety data on one of these products."
The study is not expected to start enrolling participants until early 2010. Meanwhile, people interested in volunteering for the study are encouraged to visit the Fenway website to learn more about microbicides and this research, visit www.fenwayhealth.org/microbicides.
About the Microbicide Trials Network
The Microbicide Trials Network (MTN) is an HIV/AIDS clinical trials network established in 2006 by the National Institute of Allergy and Infectious Diseases with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health. Based at Magee-Womens Research Institute and the University of Pittsburgh, the MTN brings together international investigators and community and industry partners who are devoted to preventing or reducing the sexual transmission of HIV through the development and evaluation of products applied topically to mucosal surfaces or administered orally.