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AIDS researchers from Case Western Reserve University and University Hospitals Case Medical Center have received a seven-year funding award from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
This award includes $12.7 million for core research funding and the potential of an additional $9 million to support clinical trials of promising treatments.
This award marks the fifth time the Case Western Reserve University (CWRU)/University Hospitals (UH) AIDS Clinical Trials Unit has received NIAID funding since it began operating in 1987.
"We are very proud to have received this competitive award," said co-principal investigator Michael Lederman, MD, the Scott R. Inkley Professor of Medicine and associate director of the Center for AIDS Research at Case Western Reserve School of Medicine and infectious disease specialist at UH Case Medical Center. "It shows a level of confidence in our unit that encourages and inspires us."
Benigno Rodriguez, MD, co-principal investigator and associate professor of medicine at Case Western Reserve School of Medicine and infectious disease physician at UH Case Medical Center, agreed.
"This award will not only allow us to continue our studies of treatment strategies," he said "It assures we can maintain the outstanding team that has made all this success possible."
The CWRU/UH AIDS Clinical Trials Unit is one of 37 worldwide that will conduct human studies to advance knowledge of the mechanisms of HIV-related diseases, the prevention of HIV acquisition, and the treatment of HIV/AIDS and its complications.
In addition, Cleveland's unit is one of only two U.S. centers funded as study sites for three different research networks - clinical treatment trials and prevention trials using microbicides and promising HIV vaccines. (The other center is at the University of California, San Francisco.)
The federal grant enables ongoing research on HIV and AIDS at Case Western Reserve School of Medicine.
It also supports clinical research efforts at UH Case Medical Center, the Joint Clinical Research Center in Kampala, Uganda and the University of Cincinnati, a new member which joined the CWRU/UH consortium in 2013.
Cleveland's three-trial testing designation is based on the success of its past funding and research initiatives.
The fact that researchers in this area have raised more than $195 million in grants since 2000 has helped to solidify CWRU's place as a global leader in AIDS research and it will continue to provide resources to the city to support local HIV prevention and treatment.
Lederman, Rodriguez and other unit researchers are active and recognized worldwide for their research and treatment protocols.
This success-breeds-success scenario has produced a supportive Greater Cleveland community with many volunteers who are willing to participate in trials as they become available.
For this year's award, the growing emphasis is on developing more effective methods to prevent HIV infection. The CWRU/UH AIDS Clinical Trials Unit is a part of one HIV treatment network (the AIDS Clinical Trials Group) and two HIV prevention networks: the Microbicide Trials Network and the HIV Vaccine Trials Network.
Microbicides are locally administered compounds in the form of a gel, foam or cream that could interrupt the sexual transmission of HIV.
The CWRU/UH team, in collaboration with investigators in Geneva, Switzerland and across the U.S., has pioneered a novel approach that entails blocking a component of the human cell membrane that is necessary for almost all strains of sexually-transmitted HIV to gain a foothold inside the body. Human studies are expected to begin this year.
The development of an effective vaccine to reduce HIV transmission has proven elusive so far. But the unit has been chosen to become one of 10 U.S. sites in the vaccine network, in large part because of its proven ability to attract uninfected participants to enroll in vaccine trials and its extensive expertise in HIV immunology.
This new designation means that for the next seven years the CWRU/UH AIDS Clinical Trials Unit will offer HIV prevention vaccine trials on a consistent basis in Cleveland.
Despite the life-saving effects of antiviral therapy, some HIV-infected patients experience an increased risk of illnesses related to inflammation.
During the new award period, the CWRU/UH AIDS Clinical Trials Unit will extend the scope of its research and conduct new trials aimed at interrupting the persistence of inflammation and developing strategies that target the elimination of HIV infection with the goal of cure.
The award comes with some hefty expectations. "Research conducted in the AIDS Clinical Trials Group network has so altered the course of HIV infection, that many treated patients can now achieve a normal life expectancy," said Lederman. "But many challenges remain for people with HIV-infection."
Among them are the continuing stigma associated with the virus, helping patients adhere to daily treatment regimens, and other quality of life issues including an increased risk of heart, kidney and liver diseases and cancer.
Developing more effective methods to prevent HIV infection and fine-tuning treatments to see longer and better lives for patients remain a priority of the 37 clinical trial units, Rodriguez added.