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Case Clinical Trials Unit

Award Number: UM1AI069501
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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ABSTRACT The Case Clinical Trials Unit (CTU) comprises three highly productive clinical research sites: Case/UHC in Cleveland, the University of Cincinnati, and the Joint Clinical Research Center in Kampala. Each of these three 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 portfolio with our basic and translational research programs. Thus, the three 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, Antiretroviral Medications, HIV Eradication and Cure, Tuberculosis, and Hepatitis. The Case/UHC CRS has also been a productive member of the HVTN. The Case/UHC CRS has been a high- performing site in this network, having enrolled participants, including some from difficult-to-reach segments of the population, into multiple HVTN trials during this funding cycle. In some cases, enrollment has substantially exceeded expectations from the site. Additionally, Case CTU investigators are highly accomplished researchers who have extensive experience in the monitoring of immune responses form immunization, in evaluating diverse immunization strategies to enhance vaccine responsiveness, and in the use of vaccine responsiveness as a readout of immune competence. 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, and is the number 1 site by number of participants enrolled in the US. In addition to their extraordinary performance on enrollments, the site has extensive accumulated expertise in the metabolic complications of HIV, and is additionally a high-performing protocol-specific HPTN site. The JCRC is one of the top-performing international sites in the ACTG, and is the critical component in the contributions of the Case CTU to the tuberculosis agenda. It is also the site of the first hepatitis C treatment clinical trial in Africa, the ACTG A5360 protocol. The JCRC CRS has also previously demonstrated its ability to access large numbers of subjects in well-defined populations at high risk for HIV infection, having been the site of the first HIV vaccine trial in Africa, and can begin contributing to the HIV prevention networks immediately as well if selected as a site. Thus, the three CRS that comprise this CTU are positioned to provide sustained leadership and contribution to the treatment and prevention agenda of the NIAID Networks.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $1,368,459 )
2025	2025	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	000	19	11/25/2024	NON-COMPETING CONTINUATION	$1,368,459
														Subtotal = $1,368,459

Issue Date FY: 2024 ( Subtotal = $2,393,908 )
2024	2024	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	001	18	6/5/2024	NON-COMPETING CONTINUATION	$1,196,953
2024	2024	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	000	18	11/13/2023	NON-COMPETING CONTINUATION	$1,196,955
														Subtotal = $2,393,908

Issue Date FY: 2023 ( Subtotal = $2,436,364 )
2023	2023	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	001	17	6/1/2023	NON-COMPETING CONTINUATION	$1,437,359
2023	2023	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	000	17	11/29/2022	NON-COMPETING CONTINUATION	$999,005
														Subtotal = $2,436,364

Issue Date FY: 2022 ( Subtotal = $2,582,654 )
2022	2022	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	001	16	6/9/2022	NON-COMPETING CONTINUATION	$1,007,235
2022	2022	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	000	16	11/30/2021	NON-COMPETING CONTINUATION	$1,575,419
														Subtotal = $2,582,654

Issue Date FY: 2021 ( Subtotal = $2,473,176 )
2021	2021	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	001	15	5/28/2021	COMPETING CONTINUATION	$1,287,838
2021	2021	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	000	15	11/19/2020	COMPETING CONTINUATION	$1,287,840
2021	2021	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	003	15	8/10/2021	COMPETING CONTINUATION	$235,906
2021	2020	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	002	14	8/10/2021	NON-COMPETING CONTINUATION	-$235,906
2021	2020	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	004	14	8/10/2021	SUPPLEMENT FOR EXPANSION	-$102,502
														Subtotal = $2,473,176

Issue Date FY: 2020 ( Subtotal = $3,713,358 )
2020	2020	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	001	14	6/1/2020	SUPPLEMENT FOR EXPANSION	$601,237
2020	2020	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	000	14	11/18/2019	NON-COMPETING CONTINUATION	$1,556,061
2020	2020	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	002	14	6/2/2020	NON-COMPETING CONTINUATION	$1,556,060
2020	2020	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	003	14	8/25/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $3,713,358

Issue Date FY: 2019 ( Subtotal = $3,708,628 )
2019	2019	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	002	13	9/3/2019	NON-COMPETING CONTINUATION	$40,740
2019	2019	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	003	13	9/5/2019	NON-COMPETING CONTINUATION	$0
2019	2019	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	000	13	11/16/2018	NON-COMPETING CONTINUATION	$1,833,945
2019	2019	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	001	13	5/13/2019	NON-COMPETING CONTINUATION	$1,833,943
														Subtotal = $3,708,628

Issue Date FY: 2018 ( Subtotal = $1,815,053 )
2018	2018	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	003	12	9/7/2018	NON-COMPETING CONTINUATION	$0
2018	2018	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	001	12	2/23/2018	NON-COMPETING CONTINUATION	$302,509
2018	2018	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	002	12	5/16/2018	NON-COMPETING CONTINUATION	$907,526
2018	2018	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	000	12	11/22/2017	NON-COMPETING CONTINUATION	$605,018
														Subtotal = $1,815,053

Issue Date FY: 2017 ( Subtotal = $1,977,369 )
2017	2017	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	001	11	8/25/2017	NON-COMPETING CONTINUATION	$103,025
2017	2017	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	000	11	11/10/2016	NON-COMPETING CONTINUATION	$1,874,344
														Subtotal = $1,977,369

Issue Date FY: 2016 ( Subtotal = $2,553,716 )
2016	2016	CASE WESTERN RESERVE UNIVERSITY	2040 ADELBERT ROAD	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	001	10	8/4/2016	NON-COMPETING CONTINUATION	$258,069
2016	2016	CASE WESTERN RESERVE UNIVERSITY	2040 ADELBERT ROAD	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	002	10	8/18/2016	NON-COMPETING CONTINUATION	$124,380
2016	2016	CASE WESTERN RESERVE UNIVERSITY	2040 ADELBERT ROAD	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	000	10	11/10/2015	NON-COMPETING CONTINUATION	$2,171,267
														Subtotal = $2,553,716

Issue Date FY: 2015 ( Subtotal = $1,908,328 )
2015	2015	CASE WESTERN RESERVE UNIVERSITY	2040 ADELBERT ROAD	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	000	9	11/21/2014	NON-COMPETING CONTINUATION	$1,908,328
														Subtotal = $1,908,328

Issue Date FY: 2014 ( Subtotal = $3,065,181 )
2014	2014	CASE WESTERN RESERVE UNIVERSITY	2040 ADELBERT ROAD	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	001	8	12/23/2013	COMPETING CONTINUATION	$1,079,051
2014	2014	CASE WESTERN RESERVE UNIVERSITY	2040 ADELBERT ROAD	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	000	8	12/10/2013	COMPETING CONTINUATION	$1,682,535
2014	2014	CASE WESTERN RESERVE UNIVERSITY	2040 ADELBERT ROAD	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	002	8	2/26/2014	COMPETING CONTINUATION	$303,595
														Subtotal = $3,065,181

Issue Date FY: 2013 ( Subtotal = $2,944,131 )
2013	2013	CASE WESTERN RESERVE UNIVERSITY	2040 ADELBERT ROAD	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	001	7	6/28/2013	NON-COMPETING CONTINUATION	$324,413
2013	2013	CASE WESTERN RESERVE UNIVERSITY	2040 ADELBERT ROAD	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	000	7	11/28/2012	NON-COMPETING CONTINUATION	$2,619,718
														Subtotal = $2,944,131

Issue Date FY: 2012 ( Subtotal = $3,176,040 ) (Continued on the next page)
2012	2012	CASE WESTERN RESERVE UNIVERSITY	2040 ADELBERT ROAD	CLEVELAND	OH	44106	CUYAHOGA	USA	Allergy and Infectious Diseases Research	002	6	8/6/2012	NON-COMPETING CONTINUATION	$87,606
Grand Total All Awards = $36,116,365

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Case Clinical Trials Unit

Award Number: UM1AI069501

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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