# Urine Colorimetry for Tuberculosis Pharmacokinetics Evaluation in Children and Adults

> **NIH NIH R01** · UNIVERSITY OF VIRGINIA · 2021 · $202,634

## Abstract

PROJECT SUMMARY
Approach: We propose to test the hypotheses that rifapentine and moxifloxacin urine kinetics will predict
relevant serum pharmacokinetic parameters of peak serum concentration (Cmax) and the area under the
concentration time curve (AUC0-24hours), and that those urine concentrations can be further quantified by
spectrophotometric (colorimetric) assays.
Innovation: A urine colorimetric assay for rifapentine and moxifloxacin, two critical drugs in the novel regimen
to shorten tuberculosis (TB) treatment duration, could provide a same-day clinical result of pharmacokinetic
exposure in settings without access to chromatography or mass spectrometry. Both rifapentine (which requires
ingestion of a high fat meal) and moxifloxacin pharmacokinetics may be more significantly altered when the
novel regimen is scaled beyond the clinical trial. Consequently, urine colorimetry may prove superior to limited
blood draws currently practiced to estimate Cmax or AUC0-24 given the kinetics of drug accumulation in the urine.
Impact: Successful completion of these studies will determine the applicability of urine drug kinetics for
personalized dosing strategies in rifapentine and moxifloxacin containing anti-TB drug regimens to correct a
significant component of TB treatment failure.
Significance: Despite curative antibiotics, TB treatment failure is common, leading to morbidity, mortality and
acquired drug resistance. Individual pharmacokinetic variability is a primary driver of TB treatment failure
leading to drug exposures that are suboptimal for microbial kill. Personalized dose adjustment based on an
individual’s serum pharmacokinetics is out-of-reach for the majority of people suffering from TB globally.
Environment: Dr. Mohamed’s research complements the aims of the funded parent grant which is currently
optimizing later stage urine colorimetric assays for field use in the conventional anti-TB regimen of isoniazid,
rifampin, pyrazinamide and ethambutol. Dr. Mohamed joins an international team of researchers with expertise
in TB science including pharmacology, assay development and interventional research (led by PI and primary
mentor, Dr. Heysell). Dr. Mohamed’s career development will also be supported by seasoned mentor and
Division Chief of Infectious Diseases (Dr. Houpt), and importantly, a near-peer junior faculty who has
transitioned from a Diversity Supplement support to independent funding (Dr. Moonah).
Diversity Supplement Award: The career development plan in this proposal will augment the direct scientific
mentorship through the combination of active guidance from internal and external advisory teams (participation
in Building Up a Diverse Pipeline of the Biomedical Research Workforce program), technical training/courses
and presentation at national/international meetings with the planned goal of submission of two career
development awards on the pathway to becoming an independent physician-scientist.

## Key facts

- **NIH application ID:** 10320620
- **Project number:** 3R01AI137080-05S1
- **Recipient organization:** UNIVERSITY OF VIRGINIA
- **Principal Investigator:** Scott K Heysell
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $202,634
- **Award type:** 3
- **Project period:** 2018-09-24 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10320620

## Citation

> US National Institutes of Health, RePORTER application 10320620, Urine Colorimetry for Tuberculosis Pharmacokinetics Evaluation in Children and Adults (3R01AI137080-05S1). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/10320620. Licensed CC0.

---

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