Chicago Clinical Trials Unit

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Project Summary. The Chicago Clinical Trials Unit (CCTU) is a consortium of four Clinical Research Sites (CRSs) which will address two priority clinical research areas of the NIAID: 1) adult HIV/AIDS therapeutic strategies, including novel therapeutics, HIV cure, noninfectious comorbidities, and infectious comorbidities of hepatitis B and tuberculosis; and 2) integrated HIV prevention strategies, including novel long-acting ARV- based HIV prevention agents and delivery systems for Pre-exposure Prophylaxis (PrEP), multi-purpose prevention technologies, integrated biomedical and socio-behavioral HIV prevention strategies, and collaborative protocols with the HIV Vaccines Network testing antibody-mediated prevention strategies. The CCTU consists of four highly experienced and scientifically productive CRSs that are uniquely positioned to develop, implement and adapt the clinical research priorities of the NIAID clinical research priority areas. The CCTU has a proven track record and will continue its productivity through active engagement with a diverse host of at-risk and HIV-impacted communities, participation in high impact, ground-breaking clinical research studies, efficient management of resources and critical performance oversight of the clinical activities, laboratories, and pharmacies. Compliance with all relevant rules and regulations is a priority of the consortium. The CCTU includes CRSs and personnel that have long-term productive involvement with the two research networks with which the CCTU is affiliated, and platforms for inter-network collaboration with the other NIAID networks. The CRSs and their network affiliations are: Northwestern University (adult HIV/AIDS therapeutic strategies); Rush University (adult HIV/AIDS therapeutic strategies); Trinity Health & Wellness Center (adult HIV/AIDS therapeutic strategies); and The Ruth L. Rothstein CORE Center (HIV prevention and adult HIV/AIDS therapeutic strategies). The cities of Chicago and Dallas, where the CRSs are located, are in Cook and Dallas counties, two of the 48 “hot spots” counties where half of new HIV diagnoses in the US were concentrated in 2016 and 2017. The aims of this proposal are: development, implementation and adaptation of the clinical research program of the 1) Adult HIV/AIDS Therapeutics Strategies Clinical Trials Network in four CRSs, and 2) HIV Prevention Network in one CRS, in synergy with all CCTU elements, and 3) To ensure all CCTU research is relevant to HIV impacted populations and ethical through dynamic engagement of the community in all phases of the research. The CCTU is well-positioned to reach diverse populations and contribute significantly to the NIAID research agenda. RELEVANCE: The phenomenal scientific advances in HIV/AIDS research over the past 35 years have in large part been due to NIAID's high-impact therapeutic and prevention studies being performed by its clinical trials units (CTUs). The CCTU will continue to respond rapidly to emerging clinical research needs, engage constituents, and identify more effective treatment and prevention strategies.