# Pharmacokinetic and Programmatic Evaluations to Optimize HIV/TB Co-Treatment Regimens in Children

> **NIH NIH K23** · BRIGHAM AND WOMEN'S HOSPITAL · 2021 · $59,008

## Abstract

PROJECT SUMMARY/ABSTRACT
The convergence of the global HIV and tuberculosis (TB) epidemics represents one of the most
urgent challenges facing global public health. Despite improved access to antiretroviral therapy (ART),
TB remains the leading killer of children with HIV. Furthermore, the task of treating children co-
infected with HIV and TB remains particularly challenging due to lack of optimal treatment regimens.
As a result, the World Health Organization (WHO) has designated the evaluation of newer treatment
options for children a research priority. To address this issue, we will combine programmatic and
pharmacokinetic (PK) analyses to critically evaluate both current and promising future treatment
regimens. We will assess current pediatric HIV/TB co-treatment options by examinig 10 years of
treatment data from over 5500 pediatric patients enrolled in the Harvard/AIDS Prevention Initiative in
Nigeria (APIN) program to identify predictors of HIV/TB treatment failure and/or mortality, with a
particular focus on ART timing and regimen selection. We will also evaluate the pharmacokinetics,
safety, and efficacy of two novel treatment strategies among co-infected children: (1) rifabutin-based
TB treatment in combination with LPV/r-based ART; and, (2) dolutegravir-based ART with concurrent
rifampin-based TB treatment, building upon emerging results from the IMPAACT P1093 study. This
combination of programmatic outcomes and PK analyses will provide critical data to advance the
treatment of pediatric HIV/TB co-infection.
The Harvard/APIN PEPFAR program has supported HIV care services for over 150,000 people in
Nigeria including over 5500 children since 2004. Children enrolled in this program receive free clinical
care, antiretroviral therapy, TB screening, and laboratory monitoring. This study will build upon this
well-established HIV treatment program to examine issues critical for efforts to improve pediatric
HIV/TB outcomes. Nigeria is home to more children living with HIV than any other country, with
60,0000 children newly infected with HIV in 2012 alone. By critically evaluating our current efforts and
performing PK studies to evaluate two novel co-treatment regimens, we will gain essential knowledge
that may translate into a change in treatment recommendations and begin to curb TB’s devastating
toll.

## Key facts

- **NIH application ID:** 10422433
- **Project number:** 3K23AI125122-05S1
- **Recipient organization:** BRIGHAM AND WOMEN'S HOSPITAL
- **Principal Investigator:** Holly Elizabeth Rawizza
- **Activity code:** K23 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $59,008
- **Award type:** 3
- **Project period:** 2021-09-03 → 2022-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10422433

## Citation

> US National Institutes of Health, RePORTER application 10422433, Pharmacokinetic and Programmatic Evaluations to Optimize HIV/TB Co-Treatment Regimens in Children (3K23AI125122-05S1). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10422433. Licensed CC0.

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