Pitt-Led Microbicide Trials Network Awarded $70 Million Over Seven Years to Develop, Test HIV Prevention Products

The National Institutes of Health has awarded $70 million to the Microbicide Trials Network, a research program based at the University of Pittsburgh and Magee-Womens Research Institute that is developing and testing products to reduce the spread of HIV, the virus that causes AIDS.

The Microbicide Trials Network was created in 2006 with funding from the National Institute of Allergy and Infectious Diseases, 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 seven-year funding means the network will continue to serve as one of five National Institute of Allergy and Infectious Diseases HIV/AIDS clinical trials networks through 2021. The network 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.

The network 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.

“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 [Microbicide Trials Network] is focused on developing products to address their unmet needs,” said coprincipal investigator Sharon Hillier, professor and director of reproductive infectious disease research, Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine.

“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,” Hillier said.

Another high priority is to address the unmet need for new HIV prevention products.

“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,” said coprincipal investigator Ian McGowan, professor of medicine, obstetrics, gynecology, and reproductive sciences at the Pitt School of Medicine. “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.”

Both Hillier and McGowan are members of the Magee-Womens Research Institute.

The Microbicide Trials Network comprises three components: a leadership and operations center, which is led by Hillier and McGowan; a laboratory center based at the Magee-Womens Research Institute and led by Charlene Dezzutti, a 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 grant supports the work of the network’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, all of which are part of clinical trials units funded by the National Institute of Allergy and Infectious Diseases.

National Institute of Allergy and Infectious Diseases officials also announced that Pitt has been awarded a seven-year, $8.7 million grant to continue as one of 37 clinical trial units for HIV/AIDS research. The clinical trial units implement the scientific agendas of the National Institute of Allergy and Infectious Diseases networks.

John Mellors, professor of medicine and chief, Division of Infectious Diseases, Pitt School of Medicine, is the principal investigator for Pitt’s clinical trial unit, which will oversee Microbicide Trials Network studies conducted at Pitt—as well as studies of the AIDS Clinical Trial Group, another National Institutes of Health-funded clinical trials network, at research sites at Pitt and Ohio State University.