Point-of-care Pharmacogenomic Testing to Optimize Isoniazid Dosing for Tuberculosis Prevention

Phase 1 Completed 78 enrolled Stanford University Federal University of Mato Grosso · collab Fiocruz Mato Grosso do Sul · collab National Institute of Allergy and Infectious Diseases (NIAID) · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This trial is designed to determine whether modifying the dose of isoniazid for individuals according to their n-acetyltransferase 2 (NAT2) genotype could increase the probability of achieving equivalence of area-under-the-curve.

Timeline

Start: 2023-03-23
Primary completion: 2025-04-23
Completion: 2025-06-25

Publications

Background Verma R, Patil S, Zhang N, Moreira FMF, Vitorio MT, Santos ADS, Wallace E, Gnanashanmugam D, Persing DH, Savic RM, Croda J, Andrews JR. A Rapid Pharmacogenomic Assay to Detect NAT2 Polymorphisms and Guide Isoniazid Dosing for Tuberculosis Treatment. Am J Respir Crit Care Med. 2021 Dec 1;204(11):1317-1326. doi: 10.1164/rccm.202103-0564OC.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Isoniazid	Small molecule	5 mg/kg	Oral
Subject	Isoniazid	Small molecule	15 mg/kg	Oral
Subject	Isoniazid	Small molecule	25 mg/kg	Oral

Point-of-care Pharmacogenomic Testing to Optimize Isoniazid Dosing for Tuberculosis Prevention

Summary

Timeline

Publications

Drugs

Indications