Tuesday, February 17, 2026 2/17/2026

Mind the gaps: Pharmacokinetic research to advance pediatric HIV/TB cotreatment and TB prevention

Award Number: R01HD107726
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/07/2022
PERIOD OF PERFORMANCE END DATE: 01/31/2028

Group Awards By:

View Award Description

Mind the gaps: Pharmacokinetic research to advance pediatric HIV/TB cotreatment and TB prevention - PROJECT SUMMARY Tuberculosis (TB) is the leading cause of death among children with HIV, yet insufficient data are available on the pharmacokinetics (PK) of newer HIV/TB cotreatment and TB prevention strategies in children. Global expansion of dolutegravir use for young children has the potential to significantly improve HIV treatment outcomes, but there are no PK data to inform use of double-dose dolutegravir during rifampicin-containing HIV/TB cotreatment for children under 6 years of age. Further, multiple studies have shown that current WHO-recommended rifampicin dosages result in low concentrations in most children, and high-dose rifampicin may improve outcomes and shorten treatment duration in adults and children. Yet the impact of high-dose rifampicin on dolutegravir exposures has not been examined. Finally, it is well-established that treatment of latent TB infection (LTBI) significantly reduces incident TB among HIV-infected persons, yet this strategy is vastly underused in endemic settings. Short-course LTBI treatment regimens increase completion rates, but have not been studied among HIV-infected children receiving dolutegravir. To address these gaps in knowledge and provide needed PK and safety data to extend use of these promising strategies from adults to children, we will carry out two prospective PK studies to examine: (1) twice daily dolutegravir during both standard- and high-dose rifampicin, and (2) PK of dolutegravir during weekly rifapentine/isoniazid for TB prevention/LTBI treatment. To advance our understanding of underlying mechanisms of drug action we will also examine the impact of standard- and high-dose daily rifampicin and weekly rifapentine on the 4β-hydroxy-cholesterol to cholesterol ratio, an endogenous biomarker of CYP3A4 activity. This will provide critical pharmacodynamic (PD) data for use in population PK/PD models to quantify variability and inform optimal drug dosing in this vulnerable population of children. Nigeria is home to more children living with HIV than any other country in the world, and also bears one of the greatest burdens of incident TB. Since 2004, APIN Public Health Initiatives has provided HIV care and treatment to over 20,000 children in Nigeria and thus is uniquely positioned to support this vital PK research. This combination of studies addresses critical gaps in knowledge regarding PK and safety of newer drug combinations for HIV/TB cotreatment and TB prevention, findings that may inform WHO guidance on use in children, toward the goal of curbing TB’s devastating toll in this vulnerable population.


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 = $306,478 )
2026	2026	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Child Health and Human Development Extramural Research	000	4	1/28/2026	NON-COMPETING CONTINUATION	$190,326
2026	2026	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Child Health and Human Development Extramural Research	001	4	1/30/2026	SUPPLEMENT FOR EXPANSION	$66,240
2026	2026	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Child Health and Human Development Extramural Research	002	4	2/6/2026	SUPPLEMENT FOR EXPANSION	$49,912
														Subtotal = $306,478

Issue Date FY: 2025 ( Subtotal = $306,478 )
2025	2025	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Child Health and Human Development Extramural Research	003	3	8/12/2025	SUPPLEMENT FOR EXPANSION	$49,912
2025	2025	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Child Health and Human Development Extramural Research	002	3	8/8/2025	SUPPLEMENT FOR EXPANSION	$66,240
2025	2025	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Child Health and Human Development Extramural Research	001	3	8/7/2025	NON-COMPETING CONTINUATION	$0
2025	2025	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Child Health and Human Development Extramural Research	000	3	8/1/2025	NON-COMPETING CONTINUATION	$190,326
														Subtotal = $306,478

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Child Health and Human Development Extramural Research	000	2	2/22/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $307,054 )
2023	2023	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Child Health and Human Development Extramural Research	000	2	1/24/2023	NON-COMPETING CONTINUATION	$307,054
														Subtotal = $307,054

Issue Date FY: 2022 ( Subtotal = $322,814 )
2022	2022	BRIGHAM AND WOMEN'S HOSPITAL, INC., THE	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Child Health and Human Development Extramural Research	000	1	4/7/2022	NEW	$322,814
														Subtotal = $322,814

Grand Total All Awards = $1,242,824

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Mind the gaps: Pharmacokinetic research to advance pediatric HIV/TB cotreatment and TB prevention

Award Number: R01HD107726

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 04/07/2022

PERIOD OF PERFORMANCE END DATE: 01/31/2028

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer