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The FIOCRUZ Therapeutic and Prevention HIV/AIDS Clinical Trials Unit.

Award Number: UM1AI069476
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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FioTrials Abstract The FioTrials CTU, based at the Oswaldo Cruz Foundation - FIOCRUZ (Rio de Janeiro, Brazil), is led by Dr. Beatriz Grinsztejn and supported by a cadre of experienced researchers and promising junior investigators. FioTrials is affiliated with FIOCRUZ, an international center of excellence in the field of public health and infectious diseases. The FioTrials CTU promotes and rewards innovation, while providing a standardized, formal approach to the implementation and management of clinical trials. The CTU has successfully implemented and conducted pivotal clinical trials for multiple NIH-sponsored Networks that have changed the landscape of HIV and Tuberculosis (TB) prevention and treatment during the last 14 years. The FioTrials Clinical Research Site (CRS), Instituto de Pesquisa Clinica Evandro Chagas (IPEC CRS), has created an extensive record of accomplishment in conducting clinical research at a hospital-based setting and has continuously proven to be an elite performer CRS. The IPEC CRS is committed to ensuring that all of its processes and standards meet or supersede the requirements for DAIDS-sponsored networks, ICH/GCP standards, and other regulatory authorities. The CRS has not only contributed to the generation of results that led to improved care and treatment for those infected with and affected by HIV, tuberculosis, and hepatitis and their associated comorbidities, but also to the licensure applications for 11 novel agents. The FioTrials CTU and the IPEC CRS have successfully undergone regulatory inspections from both US (FDA) and European (EMA) authorities. FioTrials and the IPEC CRS have established a solid relationship with the local HIV/AIDS and LGBTQI+ communities. Our program success is the result of a dynamic and collaborative process with different stakeholders, such as study participants and communities, community leaders and advocates, nongovernmental organizations, researchers, relevant governmental bodies, and health care providers. The CTU and CRS teams are composed of individuals and researchers with diverse social and professional backgrounds, gender, sexual orientation, race, beliefs, and values that well represent the communities we serve. During this next funding cycle, we look forward to the opportunity to contributing to the scientific and functional goals of the ACTG, HPTN, and HVTN networks. Together with our DAIDS Network partners, we aim to enhance the landscape for HIV, TB, and Hepatitis treatment and prevention.


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 = $205,952 )
2025	2025	FUNDACAO OSWALDO CRUZ	AVENIDA BRASIL 4365 QUININO, SALA 303	RIO DE JANEIRO				BRA	Allergy and Infectious Diseases Research	000	18	11/22/2024	NON-COMPETING CONTINUATION	$205,952
														Subtotal = $205,952

Issue Date FY: 2024 ( Subtotal = $1,303,154 )
2024	2024	FUNDACAO OSWALDO CRUZ	AVENIDA BRASIL 4365 QUININO, SALA 303	RIO DE JANEIRO				BRA	Allergy and Infectious Diseases Research	000	17	10/27/2023	NON-COMPETING CONTINUATION	$699,393
2024	2024	FUNDACAO OSWALDO CRUZ	AVENIDA BRASIL 4365 QUININO, SALA 303	RIO DE JANEIRO				BRA	Allergy and Infectious Diseases Research	001	17	5/31/2024	NON-COMPETING CONTINUATION	$603,761
														Subtotal = $1,303,154

Issue Date FY: 2023 ( Subtotal = $1,528,344 )
2023	2023	FUNDACAO OSWALDO CRUZ	AV BRASIL 4365 QUININO, SALA 303	RIO DE JANEIRO				BRA	Allergy and Infectious Diseases Research	001	16	5/25/2023	NON-COMPETING CONTINUATION	$791,002
2023	2023	FUNDACAO OSWALDO CRUZ	AV BRASIL 4365 QUININO, SALA 303	RIO DE JANEIRO				BRA	Allergy and Infectious Diseases Research	000	16	11/16/2022	NON-COMPETING CONTINUATION	$737,342
														Subtotal = $1,528,344

Issue Date FY: 2022 ( Subtotal = $1,747,343 )
2022	2022	FUNDACAO OSWALDO CRUZ.	AV. BRASIL 4.365, C. DE REL. INTE. EM SAUDE	RIO DE JANEIRO	RJ			BRA	Allergy and Infectious Diseases Research	001	15	7/21/2022	NON-COMPETING CONTINUATION	$663,018
2022	2022	FUNDACAO OSWALDO CRUZ.	AV. BRASIL 4.365, C. DE REL. INTE. EM SAUDE	RIO DE JANEIRO	RJ			BRA	Allergy and Infectious Diseases Research	002	15	7/26/2022	NON-COMPETING CONTINUATION	$0
2022	2022	FUNDACAO OSWALDO CRUZ.	AV. BRASIL 4.365, C. DE REL. INTE. EM SAUDE	RIO DE JANEIRO	RJ			BRA	Allergy and Infectious Diseases Research	000	15	11/22/2021	NON-COMPETING CONTINUATION	$1,084,325
														Subtotal = $1,747,343

Issue Date FY: 2021 ( Subtotal = $2,790,912 )
2021	2021	FUNDACAO OSWALDO CRUZ.	AV. BRASIL 4.365, C. DE REL. INTE. EM SAUDE	RIO DE JANEIRO	RJ			BRA	Allergy and Infectious Diseases Research	003	14	9/10/2021	COMPETING CONTINUATION	$0
2021	2021	FUNDACAO OSWALDO CRUZ.	AV. BRASIL 4.365, C. DE REL. INTE. EM SAUDE	RIO DE JANEIRO	RJ			BRA	Allergy and Infectious Diseases Research	002	14	9/1/2021	COMPETING CONTINUATION	$1,395,456
2021	2021	FUNDACAO OSWALDO CRUZ.	AV. BRASIL 4.365, C. DE REL. INTE. EM SAUDE	RIO DE JANEIRO	RJ			BRA	Allergy and Infectious Diseases Research	000	14	11/20/2020	COMPETING CONTINUATION	$1,395,456
2021	2020	FUNDACAO OSWALDO CRUZ.	AV. BRASIL 4.365, C. DE REL. INTE. EM SAUDE	RIO DE JANEIRO	RJ			BRA	Allergy and Infectious Diseases Research	001	13	8/10/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $2,790,912

Issue Date FY: 2020 ( Subtotal = $2,006,794 )
2020	2020	FUNDACAO OSWALDO CRUZ.	AV. BRASIL 4.365, C. DE REL. INTE. EM SAUDE	RIO DE JANEIRO	RJ	21040-360		BRA	Allergy and Infectious Diseases Research	001	13	5/20/2020	NON-COMPETING CONTINUATION	$1,003,395
2020	2020	FUNDACAO OSWALDO CRUZ.	AV. BRASIL 4.365, C. DE REL. INTE. EM SAUDE	RIO DE JANEIRO	RJ	21040-360		BRA	Allergy and Infectious Diseases Research	000	13	11/20/2019	NON-COMPETING CONTINUATION	$1,003,399
														Subtotal = $2,006,794

Issue Date FY: 2019 ( Subtotal = $2,828,231 )
2019	2019	FUNDACAO OSWALDO CRUZ.	AV. BRASIL 4.365, C. DE REL. INTE. EM SAUDE	RIO DE JANEIRO	RJ	21040-360		BRA	Allergy and Infectious Diseases Research	000	12	11/15/2018	NON-COMPETING CONTINUATION	$1,414,116
2019	2019	FUNDACAO OSWALDO CRUZ.	AV. BRASIL 4.365, C. DE REL. INTE. EM SAUDE	RIO DE JANEIRO	RJ	21040-360		BRA	Allergy and Infectious Diseases Research	001	12	5/16/2019	NON-COMPETING CONTINUATION	$1,414,115
														Subtotal = $2,828,231

Issue Date FY: 2018 ( Subtotal = $773,601 )
2018	2018	FUNDACAO OSWALDO CRUZ.	AV. BRASIL 4.365, C. DE REL. INTE. EM SAUDE	RIO DE JANEIRO	RJ	21040-360		BRA	Allergy and Infectious Diseases Research	001	11	2/12/2018	NON-COMPETING CONTINUATION	$128,934
2018	2018	FUNDACAO OSWALDO CRUZ.	AV. BRASIL 4.365, C. DE REL. INTE. EM SAUDE	RIO DE JANEIRO	RJ	21040-360		BRA	Allergy and Infectious Diseases Research	000	11	11/24/2017	NON-COMPETING CONTINUATION	$257,867
2018	2018	FUNDACAO OSWALDO CRUZ.	AV. BRASIL 4.365, C. DE REL. INTE. EM SAUDE	RIO DE JANEIRO	RJ	21040-360		BRA	Allergy and Infectious Diseases Research	002	11	5/10/2018	NON-COMPETING CONTINUATION	$386,800
														Subtotal = $773,601

Issue Date FY: 2017 ( Subtotal = $1,397,306 )
2017	2017	FUNDACAO OSWALDO CRUZ.	AV. BRASIL 4.365, C. DE REL. INTE. EM SAUDE	RIO DE JANEIRO	RJ	21040-360		BRA	Allergy and Infectious Diseases Research	000	10	11/17/2016	NON-COMPETING CONTINUATION	$607,626
2017	2017	FUNDACAO OSWALDO CRUZ.	AV. BRASIL 4.365, C. DE REL. INTE. EM SAUDE	RIO DE JANEIRO	RJ	21040-360		BRA	Allergy and Infectious Diseases Research	005	10	8/10/2017	NON-COMPETING CONTINUATION	$0
2017	2017	FUNDACAO OSWALDO CRUZ.	AV. BRASIL 4.365, C. DE REL. INTE. EM SAUDE	RIO DE JANEIRO	RJ	21040-360		BRA	Allergy and Infectious Diseases Research	006	10	8/14/2017	NON-COMPETING CONTINUATION	$0
2017	2017	FUNDACAO OSWALDO CRUZ.	AV. BRASIL 4.365, C. DE REL. INTE. EM SAUDE	RIO DE JANEIRO	RJ	21040-360		BRA	Allergy and Infectious Diseases Research	001	10	12/2/2016	NON-COMPETING CONTINUATION	$0
2017	2017	FUNDACAO OSWALDO CRUZ.	AV. BRASIL 4.365, C. DE REL. INTE. EM SAUDE	RIO DE JANEIRO	RJ	21040-360		BRA	Allergy and Infectious Diseases Research	004	10	7/26/2017	NON-COMPETING CONTINUATION	$789,680
2017	2015	FUNDACAO OSWALDO CRUZ.	AV. BRASIL 4.365, C. DE REL. INTE. EM SAUDE	RIO DE JANEIRO	RJ	21040-360		BRA	Allergy and Infectious Diseases Research	003	8	6/26/2017	NON-COMPETING CONTINUATION	-$265,143
2017	2013	FUNDACAO OSWALDO CRUZ.	AV. BRASIL 4.365, C. DE REL. INTE. EM SAUDE	RIO DE JANEIRO	RJ	21040-360		BRA	Allergy and Infectious Diseases Research	002	6	6/26/2017	EXTENSION WITH OR WITHOUT FUNDS	$265,143
														Subtotal = $1,397,306

Issue Date FY: 2016 ( Subtotal = $1,104,340 )
2016	2016	FIOTEC	AV BRASIL 4036 - MANGUINHOS	RIO DE JANEIRO				BRA	Allergy and Infectious Diseases Research	000	9	11/16/2015	NON-COMPETING CONTINUATION	$773,601
2016	2016	FIOTEC	AV BRASIL 4036 - MANGUINHOS	RIO DE JANEIRO				BRA	Allergy and Infectious Diseases Research	001	9	8/15/2016	NON-COMPETING CONTINUATION	$330,739
														Subtotal = $1,104,340

Issue Date FY: 2015 ( Subtotal = $1 )
2015	2015	FIOTEC	AV BRASIL 4036 - MANGUINHOS	RIO DE JANEIRO				BRA	Allergy and Infectious Diseases Research	000	8	1/15/2015	NON-COMPETING CONTINUATION	$1
														Subtotal = $1

Issue Date FY: 2014 ( Subtotal = $1,995,627 )
2014	2014	FIOTEC	AV BRASIL 4036 - MANGUINHOS	RIO DE JANEIRO				BRA	Allergy and Infectious Diseases Research	002	7	12/23/2013	COMPETING CONTINUATION	$1,206,262
2014	2014	FIOTEC	AV BRASIL 4036 - MANGUINHOS	RIO DE JANEIRO				BRA	Allergy and Infectious Diseases Research	003	7	2/28/2014	COMPETING CONTINUATION	$201,943
2014	2014	FIOTEC	AV BRASIL 4036 - MANGUINHOS	RIO DE JANEIRO				BRA	Allergy and Infectious Diseases Research	001	7	12/10/2013	COMPETING CONTINUATION	$587,422
2014	2013	FIOTEC	AV BRASIL 4036 MANGUINHOS	BRAZIL					Allergy and Infectious Diseases Research	000	6	12/9/2013	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $1,995,627

Issue Date FY: 2013 ( Subtotal = $3,247,921 ) (Continued on the next page)
2013	2013	FIOTEC	AV BRASIL 4036 - MANGUINHOS	RIO DE JANEIRO				BRA	Allergy and Infectious Diseases Research	003	6	6/10/2013	EXTENSION WITH OR WITHOUT FUNDS	$324,794
2013	2013	FIOTEC	AV BRASIL 4036 - MANGUINHOS	RIO DE JANEIRO				BRA	Allergy and Infectious Diseases Research	000	6	12/24/2012	EXTENSION WITH OR WITHOUT FUNDS	$2,923,127
2013	2013	FIOTEC	AV BRASIL 4036 MANGUINHOS	BRAZIL					Allergy and Infectious Diseases Research	004	6	12/9/2013	EXTENSION WITH OR WITHOUT FUNDS	$0
2013	2013	FIOTEC	AV BRASIL 4036 - MANGUINHOS	RIO DE JANEIRO				BRA	Allergy and Infectious Diseases Research	002	6	4/23/2013	EXTENSION WITH OR WITHOUT FUNDS	$2,923,127
Grand Total All Awards = $23,017,913

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The FIOCRUZ Therapeutic and Prevention HIV/AIDS Clinical Trials Unit.

Award Number: UM1AI069476

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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