Status:
COMPLETED
Point-of-care Pharmacogenomic Testing to Optimize Isoniazid Dosing for Tuberculosis Prevention
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Federal University of Mato Grosso
Conditions:
Tuberculosis Infection
Isoniazid Adverse Reaction
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 equival...
Eligibility Criteria
Inclusion
- Eligible for latent tuberculosis treatment by Brazil's national guidelines\*
- provides written informed consent to participate in the study
Exclusion
- 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
Key Trial Info
Start Date :
March 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2025
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT05413551
Start Date
March 23 2023
End Date
June 25 2025
Last Update
December 17 2025
Active Locations (1)
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1
Federal University of Mato Grosso do Sul
Campo Grande, Mato Grosso do Sul, Brazil