Wednesday, February 18, 2026 2/18/2026

LA HIV Treatment in Pediatrics

Award Number: R33AI149499
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/15/2020
PERIOD OF PERFORMANCE END DATE: 02/28/2026

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LA HIV Treatment in Pediatrics - PROJECT SUMMARY The long-term goal of this proposed project is to develop an innovative, end-user informed Delivery of Antiretrovirals via Implantable System for Young children (DAISY). DAISY will offer a combination of product attributes that surpass existing oral regimens for antiretroviral treatment (ART) in young children (ages 2-5): long-term ART (at least 6 months), reversibility during drug delivery, user independence, biodegradation, and discretion of use. With a focus on preferred user characteristics in the Republic of South Africa (RSA), the DAISY platform aims to extend time between clinic visits and simplify dosing regimens of antiretrovirals (ARVs) in young children to ultimately improve adherence, and thus, viral suppression, disease progression, and childhood development. The implant is uniquely retrievable, if needed, for the duration of ARV delivery, but otherwise remains stationary and biodegrades after depletion of the drug. In this manner, reversal of drug delivery is possible in the case of adverse reactions or need to change in the regimen. The implant technology also decouples drug delivery characteristics from biodegradation properties and can achieve zero-order kinetics of ARV release. The proposed specific aims directly address the goals of this National Institutes of Health opportunity (RFA-AI-18-057) for innovative long-acting drug delivery systems for treatment of HIV-1 infected children. The specific aims are to (1) develop the DAISY product, including ARV formulations, implant form factors, and characterization of biodegradation; (2) evaluate safety, pharmacokinetics, and efficacy of down-selected DAISY prototypes during preclinical studies in New Zealand White rabbits and nonhuman primates; and (3) inform technology development via iterative socio-behavior research with end-user populations in RSA. Importantly, the proposed work will leverage achievements made during earlier programs in developing the implant platform and will build on this work in the following key aspects: long-term delivery (up to 6 months) of multiple ARVs and incorporation of end-user acceptability data from RSA into a Target Product Profile. Our Research Strategy is milestone-driven, with clear expected deliverables guiding progress of product development to align with future clinical translation.


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 = -$1,410,442 )
2025	2024	RESEARCH TRIANGLE INSTITUTE	3040 CORNWALLIS RD	DURHAM	NC	27709	DURHAM	USA	Allergy and Infectious Diseases Research	000	5	7/8/2025	NON-COMPETING CONTINUATION	-$1,410,442
2025	2024	RESEARCH TRIANGLE INSTITUTE	3040 CORNWALLIS RD	DURHAM	NC	27709	DURHAM	USA	Allergy and Infectious Diseases Research	001	5	7/11/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = -$1,410,442

Issue Date FY: 2024 ( Subtotal = $1,396,180 )
2024	2024	RESEARCH TRIANGLE INSTITUTE	3040 CORNWALLIS RD	DURHAM	NC	27709	DURHAM	USA	Allergy and Infectious Diseases Research	001	5	5/23/2024	NON-COMPETING CONTINUATION	$139,619
2024	2024	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Allergy and Infectious Diseases Research	000	5	2/8/2024	NON-COMPETING CONTINUATION	$1,256,561
														Subtotal = $1,396,180

Issue Date FY: 2023 ( Subtotal = $1,468,267 )
2023	2023	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Allergy and Infectious Diseases Research	000	4	3/2/2023	NON-COMPETING CONTINUATION	$1,401,132
2023	2022	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Allergy and Infectious Diseases Research	001	3	8/4/2023	EXTENSION WITH OR WITHOUT FUNDS	$67,135
														Subtotal = $1,468,267

Issue Date FY: 2022 ( Subtotal = $1,493,953 )
2022	2022	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Allergy and Infectious Diseases Research	000	3	3/18/2022	EXTENSION WITH OR WITHOUT FUNDS	$1,493,953
2022	2022	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Allergy and Infectious Diseases Research	001	3	3/31/2022	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $1,493,953

Grand Total All Awards = $2,947,958

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LA HIV Treatment in Pediatrics

Award Number: R33AI149499

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 03/15/2020

PERIOD OF PERFORMANCE END DATE: 02/28/2026

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