Pitt Receives Grants Totaling $17.5 million for Two HIV Prevention Projects

Multicenter Studies Will Develop Rectal Microbicides and Assess Their Acceptance

PITTSBURGH, Jan. 7, 2010 – A multicenter research team led by the University of Pittsburgh is developing microbicides specifically designed to prevent rectal transmission of HIV, with the further aim of assessing their safety and efficacy in lab and early clinical studies.

Funded by an $11 million, five-year grant from the National Institutes of Health, the Combination HIV Antiretroviral Rectal Microbicide (CHARM) program includes a project that will reformulate existing antiretroviral drugs into topical preparations that can be applied to the rectum, said principal investigator Ian McGowan, M.D., Ph.D., a professor of medicine and of obstetrics, gynecology and reproductive sciences at the University of Pittsburgh School of Medicine and an investigator at the Magee-Womens Research Institute.

"Unprotected receptive anal intercourse is the highest-risk sexual activity for HIV transmission,” Dr. McGowan noted. “Vaginal microbicides already are being extensively studied, and a similar approach might be a very effective way of preventing rectal HIV transmission. It will be critical to determine whether vaginal microbicides are safe and effective when used in the rectum, and also to develop rectal-specific products.”

The rectal microbicides that the team develops will be assessed in human cell lines, intestinal tissue samples, and in animal models. After candidate agents have been developed, the CHARM program will progress to studying them in human safety trials. Collaborating research centers include the University of California, Los Angeles; Johns Hopkins University; the University of North Carolina; and CONRAD, a program of Eastern Virginia Medical School that receives substantial support from the U.S. Agency for International Development.

Dr. McGowan, along with Alex Carballo-Dieguez, Ph.D., of Columbia University, also is a principal investigator of a $6.5 million, four-year, NIH-funded project that will examine “Microbicide Safety and Acceptability in Young Men.” For the study, which will be conducted in Pittsburgh, Boston and Puerto Rico, HIV-negative men who are between 18 and 30 years old and have sex with men will be counseled about safer sex practices and provided with condoms. They will then be asked to use a placebo gel during sexual encounters and inform the researchers about their experiences with the product through an automated phone system, video interviews with research assistants and other means.

Those who are most strict about using the placebo gel will be asked to participate in the next stage of the study, which will test the rectal safety of a vaginal microbicide or a placebo.

“This project will give us greater knowledge of whether microbicides are safe, easy to use and acceptable in the real world,” Dr. McGowan said.

The University of Pittsburgh also leads the National Institutes of Health-funded Microbicide Trials Network (MTN), of which Dr. McGowan is a co-principal investigator. Headquartered at Magee-Womens Research Institute in Pittsburgh, MTN is a global clinical trials network focused on preventing the sexual transmission of HIV.

About the University of Pittsburgh School of Medicine

As one of the nation’s leading academic centers for biomedical research, the University of Pittsburgh School of Medicine integrates advanced technology with basic science across a broad range of disciplines in a continuous quest to harness the power of new knowledge and improve the human condition. Driven mainly by the School of Medicine and its affiliates, Pitt has ranked among the top 10 recipients of funding from the National Institutes of Health since 1997 and now ranks fifth in the nation, according to preliminary data for fiscal year 2008. Likewise, the School of Medicine is equally committed to advancing the quality and strength of its medical and graduate education programs, for which it is recognized as an innovative leader, and to training highly skilled, compassionate clinicians and creative scientists well-equipped to engage in world-class research. The School of Medicine is the academic partner of UPMC, which has collaborated with the University to raise the standard of medical excellence in Pittsburgh and to position health care as a driving force behind the region’s economy. For more information about the School of Medicine, see www.medschool.pitt.edu.