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Point-of-care Pharmacogenomic Testing to Optimize Isoniazid Dosing for Tuberculosis Prevention
Recruiting
Trial ID: NCT05413551
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
Professor of Medicine (Infectious Diseases)
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
Intervention(s):
drug: Low-dose isoniazid
drug: Standard dose of isoniazid
drug: High-dose isoniazid
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305