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

Launched by STANFORD UNIVERSITY · Jun 7, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether adjusting the dose of isoniazid, a medication used to prevent tuberculosis, based on a person's genetic makeup can improve treatment outcomes. Specifically, it looks at a gene called NAT2, which helps determine how quickly the body processes isoniazid. The goal is to see if this personalized approach can help more people achieve the desired level of the medication in their system, making the treatment more effective and safer.

To be eligible for this trial, participants must meet Brazil's guidelines for latent tuberculosis treatment and provide their consent to join. However, individuals with active tuberculosis, those taking certain medications that may interfere with the study drug, or those with known allergies to isoniazid cannot participate. If you join the trial, you can expect to receive careful monitoring and support throughout the study as researchers work to optimize your isoniazid dose. This trial is currently recruiting participants aged 65 to 74, and it aims to ensure that treatment for tuberculosis prevention is both effective and tailored to individual needs.

Gender

ALL

Eligibility criteria

• 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