The Case Clinical Trials Unit (CTU) comprises four highly productive clinical research sites: Case/UHC and Metro Health Medical Center in Cleveland, the University of Cincinnati and the Joint Clinical Research Center in Kampala. Each of these four CRS sites is a top performing ACTG treatment trial site with excellent accruals, outstanding performance evaluations and major roles in the leadership of the network and it is scientific productivity. A key theme of this CTU is the close link of our clinical research portfolo with our basic and translational research programs. Thus the four CRS sites of the Case CTU bring a comprehensive research plan to the enterprise. Led by faculty who are national and international leaders in their fields, these units are poised to make substantive contributions to each of the priority areas targeted by the ACTG: Inflammation/End Organ Disease, Cure, Hepatitis and Tuberculosis. The Case/UHC CRS has also been a productive member of the MTN since the network began and proposes to develop studies in the MTN of a highly effective microbicide candidate (5P12-RANTES) that it has been developing for the past 10 years. Both Case/UHC and JCRC sites provide strong rationale for inclusion in the HVTN. Case/UHC has been working with the network on HVTN 505 and has developed a model outreach program more than doubling its enrollment to this high priority HVTN trial. The University of Cincinnati CRS is a highly efficient, well-managed CRS that has been conducting clinical and translational research for the ACTG since 1987. JCRC, the site of the first HIV vaccine trial in Africa, has ready access to large numbers of subjects in well-defined populations at high risk for HIV infection and has the advanced infrastructure to become a powerful contributor to this network. Thus the four CRS sites that comprise this CTU are positioned to provide sustained leadership and contribution to the treatment and prevention agenda of the NIAID Networks.

Public Health Relevance

Key objectives of the NIAID Clinical Trials Networks include optimizing the treatment of HIV, tuberculosis and hepatitis, and testing strategies designed to prevent the spread of HIV infection in the US and the developing world. Our CTU that comprises 4 top performing clinical research sites in the US and in Uganda and is led by faculty who are national and international leaders in these fields is poised to sustain high level contributions to this enterprise through contributions to the research agendas of the ACTG, the MTN and the HVTN.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
2UM1AI069501-08
Application #
8609928
Study Section
Special Emphasis Panel (ZAI1-UKS-A (S1))
Program Officer
Welsch, Sue A
Project Start
2007-02-13
Project End
2020-11-30
Budget Start
2013-12-10
Budget End
2014-11-30
Support Year
8
Fiscal Year
2014
Total Cost
$2,761,586
Indirect Cost
$854,332
Name
Case Western Reserve University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
077758407
City
Cleveland
State
OH
Country
United States
Zip Code
44106
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Johnson, Daniel H; Venuto, Charles; Ritchie, Marylyn D et al. (2014) Genomewide association study of atazanavir pharmacokinetics and hyperbilirubinemia in AIDS Clinical Trials Group protocol A5202. Pharmacogenet Genomics 24:195-203
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