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A Clinical Trial of Three Broadly Neutralizing Antibodies and Analytic Treatment Interruption in Early-Treated Children in Botswana

Award Number: U01AI179561
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: 09/05/2023
PERIOD OF PERFORMANCE END DATE: 06/30/2028

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A Clinical Trial of Three Broadly Neutralizing Antibodies and Analytic Treatment Interruption in Early-Treated Children in Botswana - Project Summary/Abstract Novel HIV-1 treatment strategies that maintain viral suppression while allowing time off antiretroviral treatment (ART) are of high priority for the U.S. An ART-sparing intervention using potent, long-acting broadly neutralizing antibodies (bNAbs) may reduce ART toxicities during critical periods of growth and development for children with HIV, ensures adherence, and may have benefits for viral reservoir reduction and post-treatment control. bNAbs have been associated with reduction in viral reservoirs; recent studies suggest the ability to train immune responses and improve long-term outcomes. Like early-treated adults, early-treated children may have the best chance to become post-treatment controllers, but further studies are needed, including analytic treatment interruption (ATI). We completed a proof-of-concept trial showing that monthly treatment with dual bNAbs maintained viral suppression for 24 weeks without ART in 44% of early-ART treated children. We also identified specific markers for success, and showed interruption of standard ART could be safely performed. In the proposed study we will perform a multi-step interventional clinical trial that advances the field farther. While this trial must be conducted in Botswana, a high-prevalence region where the cohort of early-treated children exists at a scale not achievable in the U.S. and where the clinical infrastructure for long-term patient monitoring and follow-up is already established, the results will be directly applicable to American children born with HIV. The investigational products are all manufactured in the U.S., and the findings from this study will be directly applicable to children with HIV in the U.S. Using a novel step-wise design and an innovative bNAb rotation strategy, we will first determine the safety, pharmacokinetics (PK), dosing, and reservoir impact of 3 long-acting bNAbs when added to effective ART. We will next measure triple-bNAb treatment success after discontinuing ART. Finally, we will test for the maintenance of virologic control during an ATI. The aims of this study are (1) to determine the safety, PK and dosing of up to 24 weeks of concomitant use of triple bNAb immunotherapy and ART in ~35 early-treated children with HIV-1; (2) to determine the safety, maintenance of virologic suppression, and CD4 cell count preservation of 24 weeks of maintenance triple bNAb treatment following discontinuation of ART in selected early-treated children; and (3) to determine the safety, maintenance of virologic suppression, and CD4 cell count preservation of a 24 week ATI among two groups: a) those with markers for the lowest viral reservoir, and b) those with HIV-1 integration in predominantly non-encoding regions of the genome. At each study step, we will measure the size and cellular composition of residual viral reservoirs, and the magnitude and quality of antiviral innate and adaptive immune responses. This study represents a leap forward for combination bNAb treatment in children, and will advance the pediatric cure agenda in the U.S. by creating a roadmap to guide curative strategies for children with HIV in the U.S., directly addressing NIH priorities to advance evidencebased interventions for chronic childhood diseases and improve health outcomes for all Americans.


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: 2026 ( Subtotal = $2,150,705 )
2026	2026	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	1033 MASSACHUSETTS AVE STE 3	CAMBRIDGE	MA	02138	MIDDLESEX	USA	Allergy and Infectious Diseases Research	002	4	8/31/2026	NON-COMPETING CONTINUATION	$0
2026	2026	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	1033 MASSACHUSETTS AVE STE 3	CAMBRIDGE	MA	02138	MIDDLESEX	USA	Allergy and Infectious Diseases Research	001	4	8/5/2026	SUPPLEMENT FOR EXPANSION	$1,037,835
2026	2026	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	1033 MASSACHUSETTS AVE STE 3	CAMBRIDGE	MA	02138	MIDDLESEX	USA	Allergy and Infectious Diseases Research	000	4	7/24/2026	NON-COMPETING CONTINUATION	$1,112,870
														Subtotal = $2,150,705

Issue Date FY: 2025 ( Subtotal = $2,201,309 )
2025	2025	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	1033 MASSACHUSETTS AVE STE 3	CAMBRIDGE	MA	02138	MIDDLESEX	USA	Allergy and Infectious Diseases Research	000	3	9/3/2025	NON-COMPETING CONTINUATION	$1,311,671
2025	2025	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	1033 MASSACHUSETTS AVE STE 3	CAMBRIDGE	MA	02138	MIDDLESEX	USA	Allergy and Infectious Diseases Research	001	3	9/8/2025	SUPPLEMENT FOR EXPANSION	$889,638
														Subtotal = $2,201,309

Issue Date FY: 2024 ( Subtotal = $2,095,803 )
2024	2024	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	2	6/27/2024	NON-COMPETING CONTINUATION	$2,095,803
														Subtotal = $2,095,803

Issue Date FY: 2023 ( Subtotal = $1,799,067 )
2023	2023	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	1	9/5/2023	NEW	$1,799,067
														Subtotal = $1,799,067

Grand Total All Awards = $8,246,884

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A Clinical Trial of Three Broadly Neutralizing Antibodies and Analytic Treatment Interruption in Early-Treated Children in Botswana

Award Number: U01AI179561

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: 09/05/2023

PERIOD OF PERFORMANCE END DATE: 06/30/2028

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