Skip to main content
OpenTrials
Completed

NCT Number: NCT05413551

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tuberculosis Infection Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Isoniazid Adverse Reaction Latent Infection Latent Tuberculosis Mycobacterium Infections Tuberculosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Federal University of Mato Grosso do Sul

Campo Grande, Mato Grosso do Sul, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-dose isoniazid

Drug

Pharmacogenomic-modified dose of isoniazid - 5 mg/kg oral tablet (maximum 300 mg)

Standard dose of isoniazid

Drug

15 mg/kg oral tablet (up to 900 mg)

High-dose isoniazid

Drug

Pharmacogenomic-modified dose of isoniazid - 25 mg/kg oral tablet (maximum 1500 mg)

Primary outcomes

  1. Isoniazid Plasma Area-under-the-curve

    Time frame: Days 7 and 14 (1, 2, 8, and 24 hours post-dose)

    Area under the plasma concentration-time curve over 24 hours (AUC₀-₂₄) for isoniazid, estimated using a population pharmacokinetic model based on plasma concentrations collected at 1, 2, 8, and 24 hours post-dose on Days 7 and 14.

  2. Isoniazid Clearance

    Time frame: Days 7 and 14 (1, 2, 8, and 24 hours post-dose)

    Apparent clearance (CL) of isoniazid estimated from a population pharmacokinetic model using plasma concentration data collected at 1, 2, 8, and 24 hours post-dose on Days 7 and 14. Clearance values represent model-derived population parameter estimates. Data across the day 7 and day 14 time points are combined to provide an estimated value as a model parameter, representing the typical value per group.

Secondary outcomes

  1. Maximum Isoniazid Concentration (Cmax)

    Time frame: Days 7 and 14 (1, 2, 8, and 24 hours post-dose)

    Maximum observed plasma concentration (Cmax) of isoniazid following dosing, derived from serial plasma samples collected at 1, 2, 8, and 24 hours post-dose

  2. Isoniazid Concentration at 24 Hours

    Time frame: Days 7 and 14 (24 hours post-dose)

    Isoniazid plasma concentration measured at 24 hours post-dose.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Federal University of Mato Grosso
  • Fiocruz Mato Grosso do Sul
  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2022
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.