CompletedPhase 1

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

Brazil73 participantsStarted 2023-03-23

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Isoniazid plasma area-under-the-curve

Timeframe: 1, 2, 8, and 24 hours post-dose

Trial details

NCT IDNCT05413551

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-23

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