Case unit is among 5 chosen for microbicide research

by Bob Bucklew

Cleveland-Each day in 2007, an estimated 5,800 adults were newly infected with HIV. Almost 50% of those infected were women, mostly in low and middle income countries.

While there have been some successes in traditional HIV prevention programs, the continued pace of new infections in the developing world and in the United States demands new and innovative tools to stop the spread of the virus.

The Case Western Reserve University/ University Hospitals AIDS Clinical Trials Unit, which for the last 20 years has been conducting clinical trials for the treatment of AIDS and related complications, has recently joined the world-wide effort to develop and test a new prevention tool, an HIV microbicide.

A "microbicide" is literally any substance that will kill a microbe, such as a virus. An HIV microbicide refers to a gel, foam or cream that if applied prior to sexual intercourse would decrease or prevent the sexual transmission of HIV. There are currently no effective HIV microbicides.

Earlier this year, the AIDS Clinical Trials Unit was informed by the National Institutes of Health that it would be one of five sites in the United States, along with eight international sites, to form the newly-created Microbicide Trials Network.

"It was an honor to be chosen as one of only five sites in the United States to conduct HIV microbicide clinical trials," said Benigno Rodriguez, M.D., assistant professor of medicine at the CWRU School of Medicine. "It is a testament to the strength of our clinical trials unit and to the people of northeast Ohio that we were chosen. When we were preparing our application to join

the Microbicide Trials Network, we asked the people of Greater Cleveland to sign up to receive information on microbicides if we were chosen to participate in this endeavor. The response was wonderful, and the people who reviewed our application cited this response as an important reason to make Cleveland a part of this noble effort."

The other United States sites are in Pittsburgh, Birmingham, Puerto Rico, and New York City.

The trials conducted in Cleveland will be early stage trials, looking for safety and acceptability of the product, rather than large-scale effectiveness trials conducted in areas with a much higher number of HIVpositive people, such as in southern Africa or India. Because of this, volunteers for the initial trials will not need to be at high-risk for HIV infection. While the first trials in Cleveland are expected to be with vaginal microbicides, it is possible that future trials of rectal microbicide trials for men and women will be conducted.

“We are going to continue our very important work to develop new medicines and treatments for HIV-positive people," said Rodriguez, "but we are also very excited about this new opportunity to fight the epidemic on another front. We are looking forward to the opportunity that we, in partnership with the people of Greater Cleveland, can make a real impact, not just at home, but around the world."

For more information on clinical trials for HIV-positive people and HIV microbicide trials at Case/UH, contact Bob Bucklew at rob2@case.edu or at 216-844-2247.

Bob Bucklew is the outreach coordinator of the Case/UHC Center for AIDS Research, AIDS Clinical Trials Unit and Microbicide Trials Network.

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