Pitt-led microbicide trials network awarded $70 million over seven years to develop, test HIV prevention products

With funding of $70 million to support its effort into 2021, the Microbicide Trials Network (MTN) will continue to develop and test products that aim to reduce the spread of HIV, the virus that causes AIDS, federal officials announced yesterday (December 16th). The extensive program, which is based at the University of Pittsburgh and Magee-Womens Research Institute (MWRI), has completed 13 trials since 2006; 11 more are in progress or will begin within the year; and several new studies will be designed and implemented during the next funding period.

The MTN was created in 2006 with funding from the National Institute of Allergy and Infectious Diseases (NIAID), as well as the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all part of the National Institutes of Health. The new funding means the MTN will continue to serve as one of five NIAID HIV/AIDS clinical trials networks for the next seven years. The MTN brings together international investigators and community and industry partners whose work is focused on the development and rigorous evaluation of promising microbicides, which are products applied inside the vagina or rectum that are intended to prevent the sexual transmission of HIV.

"Although progress in the field of HIV prevention and treatment has been nothing short of breathtaking over the last decade, there are two groups who continue to have high rates of new HIV infections - young women and men who have sex with men. The MTN is focused on developing products to address their unmet needs.," said co-principal investigator Sharon Hillier, Ph.D., professor and vice chair for faculty affairs, Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, and an MWRI member. "To address the HIV epidemic in young women, we currently are conducting a large Phase III trial of a vaginal ring that women use for a month at a time. Moving forward, we are committed to developing products that could prevent both HIV and unwanted pregnancy, which would empower young women to take charge of their own reproductive health."

Another high-priority research area is to address the unmet need for new HIV prevention products for use by men who have sex with men, transgender women, and heterosexual women who have anal sex, said co-principal investigator Ian McGowan, M.D., Ph.D., professor of medicine, Division of Gastroenterology, Hepatology and Nutrition, Pitt School of Medicine, and an MWRI member.

"Ultimately, we want to identify a lubricant-like product that both men and women can use to protect themselves from acquiring HIV during anal sex," he said. "Our entire scientific agenda is focused on conducting the kind of studies that can get safe and effective HIV prevention products approved for widespread use, whether these be vaginal or rectal microbicides. Clearly, we can't end the HIV epidemic with condoms alone."

The MTN is composed of three major components: a leadership and operations center, which is led by Drs. Hillier and McGowan; a laboratory center, based at MWRI and led by Charlene Dezzutti, Ph.D., associate professor of obstetrics, gynecology and reproductive sciences, Pitt School of Medicine; and a statistical data and management center based at the Fred Hutchinson Cancer Research Center in Seattle. The $70 million from NIAID supports the work of the MTN's leadership and operations center and the laboratory center.

The network is affiliated with more than 25 clinical research sites in Africa, North America, South America and Asia, which are part of NIAID-funded clinical trials units (CTUs).

NIAID officials also announced today that Pitt has been awarded a seven-year, $8.7 million grant to continue as one of 37 CTUs for HIV/AIDS research. The CTUs are responsible for implementing the scientific agendas of NIAID's networks. John Mellors, M.D., professor of medicine and chief, division of infectious diseases, Pitt School of Medicine, is the principal investigator for the unit, which will oversee MTN studies conducted at Pitt and studies of the AIDS Clinical Trial Group (ACTG), another NIH-funded clinical trials network, at research sites at Pitt and Ohio State University. Dr. Mellors also leads the virology cores of the MTN's and ACTG's laboratory centers and the ACTG's efforts to cure HIV infection.

The MTN leadership and operations center is supported by NIAID grant UM1AI068633. The laboratory center is supported by NIAID grant UM1AI106707.

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 whose work is focused on the development and rigorous evaluation of promising microbicides - products applied inside the vagina or rectum that are intended to prevent the sexual transmission of HIV - from the earliest phases of clinical study to large-scale trials that support potential licensure of these products for widespread use. More information about the MTN is available at www.mtnstopshiv.org.