# Addressing Research Gaps to Optimize Dolutegravir-based ART in Children and Adolescents

> **NIH NIH R01** · UNIVERSITY OF FLORIDA · 2024 · $690,567

## Abstract

ABSTRACT
Despite the major advances in the treatment of human immunodeficiency virus (HIV) and HIV-associated
comorbidities, the adoption of newer regimens in children has fallen far behind that in adults. Consequently,
health outcomes of children living with HIV (CLWH) is worse than in adults. Of the CLWH receiving
antiretroviral therapy (ART) in 2022, 81% had a suppressed viral load, compared with 93% of adults aged 15
years or older. In the same year, children under 15 years old accounted for only 4% of all people living with
HIV (PLWH), but they accounted for 13% of all AIDS-related deaths. For decades, children were forced to use
adult formulations or poorly tolerated pediatric formulations with unacceptable properties (palatability, pill size,
pill burden, high dosing frequency), high toxicity profiles and low genetic barrier to resistance. Dolutegravir
(DTG) is a novel second-generation integrase strand transfer inhibitor (INSTI) that is highly efficacious, safer
and easy to use with a higher genetic barrier to the emergence of HIV drug resistance. While DTG is a
potential game changer for children, the accelerated rollout of DTG-based ART in children in low- and middle-
income countries (LMICs) occurred in the setting of limited research data in pediatric populations. Currently,
fundamental questions remain about the adequacy of the weight-band dosing of the generic pediatric DTG
scored 10 mg dispersible tablet, drug-drug interactions in the setting of treatment of latent and active
tuberculosis (TB) and overall long-term effectiveness of DTG-based ART in children. The goal of this
application is to address fundamental research gaps to assure optimal use of DTG in children and adolescents
in real-world settings. The following specific aims will be pursued: 1) To evaluate the pharmacokinetics and
safety of the generic pediatric dolutegravir 10 mg scored tablet in children with HIV with and with TB
coinfection weighing less than 20 kg. 2) To examine the pharmacokinetics and safety of weekly isoniazid and
rifapentine (3HP) in children and adolescents and the drug-drug interactions with dolutegravir in those with HIV
infection. 3) To examine the longitudinal adherence, virologic response and changes in body mass index, lipid,
glycemia, renal, and hepatic profiles in children and adolescents with HIV on DTG-based ART. The results of
this project would provide real-world data that has the potential to impact HIV treatment guidelines for children
and adolescents.

## Key facts

- **NIH application ID:** 11007541
- **Project number:** 1R01AI186847-01
- **Recipient organization:** UNIVERSITY OF FLORIDA
- **Principal Investigator:** Awewura Jacob Kwara
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $690,567
- **Award type:** 1
- **Project period:** 2024-08-05 → 2029-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11007541

## Citation

> US National Institutes of Health, RePORTER application 11007541, Addressing Research Gaps to Optimize Dolutegravir-based ART in Children and Adolescents (1R01AI186847-01). Retrieved via AI Analytics 2026-06-12 from https://api.ai-analytics.org/grant/nih/11007541. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*