. 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.

Public Health 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.

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 #
2UM1AI069471-15
Application #
10057008
Study Section
Special Emphasis Panel (ZAI1)
Program Officer
Cogliano, Nancy A
Project Start
2007-02-01
Project End
2027-11-30
Budget Start
2020-12-01
Budget End
2021-11-30
Support Year
15
Fiscal Year
2021
Total Cost
Indirect Cost
Name
Northwestern University at Chicago
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
005436803
City
Chicago
State
IL
Country
United States
Zip Code
60611
Martin, Maureen P; Naranbhai, Vivek; Shea, Patrick R et al. (2018) Killer cell immunoglobulin-like receptor 3DL1 variation modifies HLA-B*57 protection against HIV-1. J Clin Invest 128:1903-1912
Haas, David W; Bradford, Yuki; Verma, Anurag et al. (2018) Brain neurotransmitter transporter/receptor genomics and efavirenz central nervous system adverse events. Pharmacogenet Genomics 28:179-187
Gianella, Sara; Marconi, Vincent C; Berzins, Baiba et al. (2018) Genital HIV-1 Shedding With Dolutegravir (DTG) Plus Lamivudine (3TC) Dual Therapy. J Acquir Immune Defic Syndr 79:e112-e114
Robertson, K; Oladeji, B; Jiang, H et al. (2018) HIV-1 and TB Co-infection in Multinational Resource Limited Settings: Increased neurological dysfunction. Clin Infect Dis :
Taiwo, Babafemi O; Zheng, Lu; Stefanescu, Andrei et al. (2018) ACTG A5353: A Pilot Study of Dolutegravir Plus Lamivudine for Initial Treatment of Human Immunodeficiency Virus-1 (HIV-1)-infected Participants With HIV-1 RNA <500000 Copies/mL. Clin Infect Dis 66:1689-1697
Venuto, Charles S; Lim, Jihoon; Messing, Susan et al. (2018) Inflammation investigated as a source of pharmacokinetic variability of atazanavir in AIDS Clinical Trials Group protocol A5224s. Antivir Ther 23:345-351
Kelesidis, Theodoros; Moser, Carlee B; Johnston, Elizabeth et al. (2018) Brief Report: Changes in Plasma RANKL-Osteoprotegerin in a Prospective, Randomized Clinical Trial of Initial Antiviral Therapy: A5260s. J Acquir Immune Defic Syndr 78:362-366
Akpa, Onoja; Miyahara, Sachiko; Taiwo, Babafemi et al. (2018) Similar changes in neuropsychological functioning in english and spanish speaking HIV patients. Brain Behav 8:e01083
Benson, Constance A; Andersen, Janet W; Macatangay, Bernard J C et al. (2018) Safety and Immunogenicity of Zoster Vaccine Live in Human Immunodeficiency Virus-Infected Adults With CD4+ Cell Counts >200 Cells/mL Virologically Suppressed on Antiretroviral Therapy. Clin Infect Dis 67:1712-1719
MacBrayne, Christine E; Marks, Kristen M; Fierer, Daniel S et al. (2018) Effects of sofosbuvir-based hepatitis C treatment on the pharmacokinetics of tenofovir in HIV/HCV-coinfected individuals receiving tenofovir disoproxil fumarate. J Antimicrob Chemother 73:2112-2119

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