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

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.

Stanford is currently accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: Low-dose isoniazid
  • drug: Standard dose of isoniazid
  • drug: High-dose isoniazid

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

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