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

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Trial ID: NCT05413551

Age - 18 Years-N/A Gender - ALL Accepting Healthy Volunteers - No

Purpose

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.

Official Title

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

Stanford Investigator(s)

Jason Andrews
Jason Andrews

Professor of Medicine (Infectious Diseases) and, by courtesy, of Epidemology

Eligibility

Inclusion Criteria:

* Eligible for latent tuberculosis treatment by Brazil's national guidelines\*
* provides written informed consent to participate in the study

Exclusion Criteria:

* Evidence of active tuberculosis or currently under evaluation for active tuberculosis
* Receiving drugs that interact with Rifapentine (e.g. methadone, warfarin)
* Known intolerance or hypersensitivity to isoniazid or rifapentine
* Prior treatment for active or latent tuberculosis \> 14 days
* Close contact to isoniazid- or rifampicin-resistant tuberculosis (TB) case
* Neutropenia (absolute neutrophil count \<1000 cells/mm3)
* Clinical diagnosis of active liver disease or alcohol dependence
* alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 times the upper limit of normal

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Intervention(s):

drug: Low-dose isoniazid

drug: Standard dose of isoniazid

drug: High-dose isoniazid

Recruiting

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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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