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New chemotherapy regimens and biomarkers for Chagas disease

Award Number: U01AI129783
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/17/2018
PERIOD OF PERFORMANCE END DATE: 07/31/2025

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New chemotherapy regimens and biomarkers for Chagas disease - ABSTRACT Chagas disease is caused by the parasite, Trypanosoma cruzi, and affects millions of people in Latin America. Lately, Chagas disease has become an emerging worldwide public health issue due to globalization. Chagas disease has two phases: an initial acute phase, usually with nonspecific symptoms or asymptomatic, and a lifelong chronic phase, which is clinically silent or indeterminate in 60-70% of patients. However, 30-40% of chronic patients will eventually develop heart and/or digestive complications. Currently, the only approved drugs for treating Chagas disease are benznidazole (BZN) and nifurtimox (NFX). The efficacy of these drugs is variable and depends on the disease stage, drug dose, age of patients, and infecting T. cruzi strain(s). Treatment in the acute phase is effective with both drugs. However, the efficacy of these drugs in adults with chronic, long-established infections is significantly lower and variable. Moreover, the high rate of adverse events of these drugs has hampered their regular clinical use, thus <1% of patients are being treated. In this project, we propose to test four new dosing regimens of BZN and NFX. Our first hypothesis is that a lower frequency of BZN and NFX dosing, with standard or extended treatment duration, might have the same or better efficacy than the standard treatment regimens with these drugs, with fewer adverse events. Here, we plan to analyze current and novel host- and parasite-derived BMKs that have shown promising results in pilot, full clinical trials or in animal studies, providing a measure of disease state and cure. Thus, our second hypothesis is that in those patients that respond to BZN or NFX treatment the serum levels of one or more proposed BMKs will be significantly reduced or become negative within three years post-treatment. To test these two hypotheses, we propose two specific aims: Specific Aim 1: To determine the safety and efficacy of extended benznidazole or nifurtimox treatment regimens with lower dosing frequency. Specific Aim 2: To evaluate host- and parasite-derived biomarkers for the follow-up of Chagas disease chemotherapy. The information gained in this project would also allow for better-designed clinical trials with previously proposed drug combinations, in which BZN and NFX would play a central role.


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 = $0 )
2025	2024	THE UNIVERSITY OF TEXAS AT EL PASO	500 W UNIVERSITY AVE	EL PASO	TX	79968	EL PASO	USA	Allergy and Infectious Diseases Research	000	7	12/13/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $739,415 )
2024	2024	THE UNIVERSITY OF TEXAS AT EL PASO	500 W UNIVERSITY AVE	EL PASO	TX	79968	EL PASO	USA	Allergy and Infectious Diseases Research	001	7	8/5/2024	NON-COMPETING CONTINUATION	$739,415
2024	2023	THE UNIVERSITY OF TEXAS AT EL PASO	500 W UNIVERSITY AVE	EL PASO	TX	79968	EL PASO	USA	Allergy and Infectious Diseases Research	000	6	5/2/2024	EXTENSION WITH OR WITHOUT FUNDS	$0
2024	2023	THE UNIVERSITY OF TEXAS AT EL PASO	500 W UNIVERSITY AVE	EL PASO	TX	79968	EL PASO	USA	Allergy and Infectious Diseases Research	003	6	9/11/2024	EXTENSION WITH OR WITHOUT FUNDS	$146,968
2024	2022	THE UNIVERSITY OF TEXAS AT EL PASO	500 W UNIVERSITY AVE	EL PASO	TX	79968	EL PASO	USA	Allergy and Infectious Diseases Research	002	5	9/11/2024	NON-COMPETING CONTINUATION	-$146,968
														Subtotal = $739,415

Issue Date FY: 2023 ( Subtotal = $916,180 )
2023	2023	UNIVERSITY OF TEXAS AT EL PASO	500 W UNIVERSITY AVE	EL PASO	TX	79968	EL PASO	USA	Allergy and Infectious Diseases Research	000	6	7/31/2023	EXTENSION WITH OR WITHOUT FUNDS	$916,180
														Subtotal = $916,180

Issue Date FY: 2022 ( Subtotal = $1,214,881 )
2022	2022	UNIVERSITY OF TEXAS AT EL PASO	500 W UNIVERSITY AVE	EL PASO	TX	79968	EL PASO	USA	Allergy and Infectious Diseases Research	000	5	8/9/2022	NON-COMPETING CONTINUATION	$1,214,881
														Subtotal = $1,214,881

Issue Date FY: 2021 ( Subtotal = $1,234,359 )
2021	2021	UNIVERSITY OF TEXAS AT EL PASO	500 W UNIVERSITY AVE	EL PASO	TX	79968	EL PASO	USA	Allergy and Infectious Diseases Research	001	4	8/13/2021	NON-COMPETING CONTINUATION	$1,234,359
2021	2020	UNIVERSITY OF TEXAS AT EL PASO	500 W UNIVERSITY AVE	EL PASO	TX	79968	EL PASO	USA	Allergy and Infectious Diseases Research	000	3	11/24/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,234,359

Issue Date FY: 2020 ( Subtotal = $1,248,620 )
2020	2020	UNIVERSITY OF TEXAS AT EL PASO	500 W UNIVERSITY AVE	EL PASO	TX	79968	EL PASO	USA	Allergy and Infectious Diseases Research	000	3	7/17/2020	NON-COMPETING CONTINUATION	$1,248,620
														Subtotal = $1,248,620

Issue Date FY: 2019 ( Subtotal = $1,184,499 )
2019	2019	UNIVERSITY OF TEXAS AT EL PASO	500 W UNIVERSITY AVE	EL PASO	TX	79968	EL PASO	USA	Allergy and Infectious Diseases Research	001	2	7/18/2019	NON-COMPETING CONTINUATION	$1,184,499
2019	2018	UNIVERSITY OF TEXAS AT EL PASO	500 W UNIVERSITY AVE	EL PASO	TX	79968	EL PASO	USA	Allergy and Infectious Diseases Research	000	1	10/26/2018	NEW	$0
														Subtotal = $1,184,499

Issue Date FY: 2018 ( Subtotal = $1,181,878 )
2018	2018	UNIVERSITY OF TEXAS AT EL PASO	500 W UNIVERSITY AVE	EL PASO	TX	79968	EL PASO	USA	Allergy and Infectious Diseases Research	000	1	8/15/2018	NEW	$1,181,878
2018	2018	UNIVERSITY OF TEXAS AT EL PASO	500 W UNIVERSITY AVE	EL PASO	TX	79968	EL PASO	USA	Allergy and Infectious Diseases Research	001	1	8/31/2018	NEW	$0
														Subtotal = $1,181,878

Grand Total All Awards = $7,719,832

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New chemotherapy regimens and biomarkers for Chagas disease

Award Number: U01AI129783

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 08/17/2018

PERIOD OF PERFORMANCE END DATE: 07/31/2025

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