HIV/ AIDS RELATED RESEARCH PROGRAMS
The AIDS Clinical Trials Unit (ACTU) at CWRU excels in design, implementation and completion of HIV treatment trials. The ACTU was recently refunded in December 2006 for another 7 years and now has 3 Clinical Research Sites (CRS) including University Hospitals Case Medical Center (UHCMC), MetroHealth Medical Center and an international site at the Joint Clinical Research Centre in Kampala, Uganda. Unique strengths of this unit include: an experienced and stable clinical research staff, intimate linkage to a well-respected HIV care clinic, a real-time three dimensional patient data base, and expertise in immunologic monitoring of HIV treatment trials.
The AIDS Clinical Trials Unit at Case Western Reserve University and University Hospitals Case Medical Center is directed by Michael Lederman, M.D., and co-directed by Robert A. Salata, M.D., and has been continuously funded as part of the NIH collaborative AIDS Clinical Trials Group (ACTG) since 1987. In this period, the ACTU has had a consistent track record of high-level productivity and of substantive contributions to the scientific agenda of the group.
SPECIAL IMMUNOLOGY UNIT (SIU)
Approximately 1,000 HIV-infected patients receive primary care in the Special Immunology Unit at University Hospitals Case Medical Center, the primary hospital affiliate of CWRU. Of these patients, 300 are participating in clinical trials. The ACTU through the development of a satellite unit at MetroHealth Medical Center can offer state-of-the-art clinical research opportunities to infected patients at two of the major tertiary medical centers in the region.
Currently, the CWRU/UHCMC ACTU has established an international sister site for HIV-related clinical trials in Kampala, Uganda, at the Joint Clinical Research Centre (JCRC). This effort will be headed up by Robert A. Salata, M.D., in collaboration with Drs. Peter Mugyenyi and Cissy Kityo at the JCRC. Scientifically relevant clinical trial protocols will become another part of our overall HIV research effort.
Several research projects at CWRU unrelated to clinical trials are dependent on access to patients at the Special Immunology Unit; and recruitment of these patients is facilitated by the Clinical Core of the Center for AIDS Research (CFAR). Examples include studies on T cell and macrophage function in HIV infected persons in the laboratories of Drs. Boom, Lederman, Harding and Toossi.
RESEARCH AREAS
Major research areas of focus through the ACTU, CFAR and SIU include HIV pathogenesis and immune responses, vaccine trials, co-infection with HIV and hepatitis C, metabolic complications of HIV and antiretroviral therapy. Multiple faculty are involved in the studies including Michael Lederman, Robert Salata, Benigno Rodriguez, Barbara Gripshover, Grace McComsey, Michelle Lisgaris, Scott Fulton, Don Anthony, and Gopala Yadavalli.
As part of the recompetition for HIV/AIDS clinical trials research funding, CWRU/UHCMC was named as one of 6 domestic sites to be involved in the newly formed Microbicides Trials Network (MTN) to undertake studies of topical products to prevent sexual transmission of HIV infection. This is an incredibly exciting area of research for our institution to participate in. Robert Salata will be the site PI for these studies with the first protocol to begin in October 2007.
In 2007, CWRU/UHCMC was also awarded a contract from the NIH to conduct research on the oral manifestations of HIV/AIDS. Mahmoud Ghannoum is the PI with involvement of ID faculty including Michael Lederman and Robert Salata.
CFAR
The Center for AIDS Research (CFAR) at CWRU was established in 1994 and is currently headed by Michael Lederman, M.D. and Jonathan Karn, Ph.D.
The CFAR is one of nineteen Centers for AIDS Research throughout the U.S. funded by the NIH, and was successfully recompeted in 2004.
The broad goal of the CFAR is to coordinate clinical and basic research activities relevant to HIV through the provision of core support facilities, developmental grant awards, support of seminar series and symposia, and community-based education programs. There are more than 60 CFAR members working in areas of research including mycobacterial research, molecular and clinical virology, HIV immunology, clinical treatment trials, epidemiology, biomedical ethics, vaccine research and international aspects of AIDS. This center is the nidus for all AIDS-related research conducted at CWRU.
The CFAR consists of several working groups, which serve as fora for scientific and intellectual interaction/organization around immunology, international collaborations, and opportunistic infections. CFAR also supports 6 cores: Biosafety Level-3 facility, Immune Function, Molecular Biology, Clinical, Biostatistics/Epidemiology, and International. The center has fostered fruitful collaborations among the faculty. Current and future trainees have complete access to all of CFAR programs. A major international component of CFAR includes collaborations within Ugandan laboratories for the study of HIV viral fitness and anti-retroviral resistance. The CFAR also supports international HIV/AIDS research and supports a molecular virology laboratory at the JCRC in Kampala, Uganda led by Eric Arts.
Dr. Salata also has established a cohort of acutely infected women from Uganda and Zimbabwe through a contract from the NIH. Eric Arts is also involved in this research. This cohort is evaluating the natural history of HIV-1 infection in areas with different HIV subtypes, viral fitness, diversity and chemokine receptor tropism, clinical complications and antiretroviral outcomes and resistance.
Other viral infections are the subject of active study at CWRU, including the immune response to Hepatitis C in HIV (+) and (-) subjects. These studies are conducted by Don Anthony, MD/Ph.D. in collaboration with Dr. Lederman and Dr. Benigno Rodriguez. |
