Point-of-care Pharmacogenomic Testing to Optimize Isoniazid Dosing for Tuberculosis Prevention
Trial ID or NCT#
NCT05413551
Status
RECRUITING
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
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
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
Investigator(s)
View on ClinicalTrials.gov
