HIV :: Expanded AIDS research and microbicide trials to include HIV positive and uninfected people

The National Institutes of Health (NIH) has awarded multi-year, multi-million dollar grants to The Case Clinical Trials Unit centered at University Hospitals Case Medical Center (UHCMC), for expanded research options in HIV treatment development and pioneering advances of the Microbicides Trials Network.

The seven-year funding award is comprised of $2.1 million for the first year of clinical trials research as well as additional funds to support an immunology laboratory housed at Case Western Reserve University School of Medicine, one of five such funded labs in the nation. The grant will allow University Hospitals Case Medical Center, a top-ranked AIDS Clinical Trials Unit, to continue and significantly expand the work of its clinical research. The grant money will also fund collaborative sites at MetroHealth Medical Center in Cleveland and at the Joint Clinical Research Center (JCRC) in Kampala, Uganda.

“We are very pleased to have received this award,” said Michael M. Lederman, M.D., the principal investigator of the Case AIDS Clinical Trials Unit at UHCMC and Director of the Case Western Reserve University Center for AIDS Research. “The NIH-funded AIDS Clinical Trials Group [ACTG] in which our Unit has participated since 1987, has established the standards for HIV care that have resulted in the dramatic improvements in the survival and quality of life for persons with HIV infection. Many challenges remain for persons with HIV infection and addressing these challenges remains the mission of the ACTG.”

In addition to continuing its research on HIV treatment trials, the award provides funds for the Case Clinical Trials Unit to participate in the newly established Microbicides Trials Network. Microbicides refer to topical treatments in the form of a gel, foam, cream, or depot device that could decrease or prevent the sexual transmission of HIV. The development of an effective HIV microbicide has been the focus of much international attention as a promising method of slowing the spread of HIV around the world. Statistics from the Centers for Disease Control and Prevention show that approximately 40,000 people become infected with HIV each year in the United States, while over 4 million people become infected each year with HIV around the world.

“By joining the new Microbicides Trials Network,” Dr. Lederman continued, “we will be able to bring our local researchers into collaboration with an international network focused on topical strategies to prevent HIV transmission. We will also be able to provide Greater Clevelanders with the opportunity to participate in research that could directly save millions of lives.”

The funding of the clinical research site in Uganda stems from a successful HIV-research collaboration between Case Western Reserve University School of Medicine and the Joint Clinical Research Centre (JCRC) in Kampala that began in 1991. “The opening of the clinical research site in Uganda reflects a strong collaborative relationship between the two institutions, and the dedication and hard work of physicians and staff in both Uganda and Cleveland,” said Robert A. Salata, MD, Chief of Division of Infectious Diseases and HIV Medicine at University Hospitals Case Medical Center and Co-Principal Investigator of the Case Medical Center Clinical Trials Unit. The Ugandan Clinical Research Site will be under the leadership of Peter Mugyeni, M.D., of the JCRC.

The AIDS Clinical Trials Group, the largest AIDS-related research consortium in the world, has been at the forefront of the medical advances which have dramatically improved the clinical care, survival and quality of life of HIV-positive people. The Group has been integrally involved in the development of new antiretroviral medications, the testing of novel immune-based therapies, and treatments for HIV-related opportunistic infections. During the new award period, the Group will expand the scope of its research to conduct clinical trials for acutely infected people, designing interventions for people who have recently become infected with HIV and the design of preventive strategies for persons who have not become infected with HIV.

“One key element to our past and future success is the continued interest of physicians, patients and healthy volunteers in our research trials,” says Dr. Benigno Rodriguez, Co-investigator in the ACTU.

Since 2000, Case Western Reserve University School of Medicine researchers have brought over $125 million to Cleveland to conduct AIDS-related research. In addition to the AIDS Clinical Trials Unit, Case Western Reserve University is home to one of 20 Centers for AIDS Research (CFAR) located in the United States. The CFAR program was established by the NIH to promote collaboration between basic and clinical researchers on AIDS-related projects, emphasizing translational research in which findings from the laboratory are brought to the clinic and vice versa.

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