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

NCT ID: NCT05413551

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-23

Study Completion Date

2025-06-25

Brief Summary

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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.

Detailed Description

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Conditions

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Tuberculosis Infection Isoniazid Adverse Reaction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rapid acetylator

Participants will receive 1 standard dose (Day 0), followed by 1 higher dose (Day 7), follow by 2 standard doses (Days 14 and 21).

Group Type EXPERIMENTAL

Standard dose of isoniazid

Intervention Type DRUG

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

High-dose isoniazid

Intervention Type DRUG

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

Intermediate acetylator

Participants will receive 4 standard doses (Days 0, 7, 14 and 21).

Group Type ACTIVE_COMPARATOR

Standard dose of isoniazid

Intervention Type DRUG

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

Slow acetylator

Participants will receive 2 standard doses (Days 0 and 7), followed by 1 lower dose (Day 21), follow by 1 standard dose (Day 21).

Group Type EXPERIMENTAL

Low-dose isoniazid

Intervention Type DRUG

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

Standard dose of isoniazid

Intervention Type DRUG

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

Interventions

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Low-dose isoniazid

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

Intervention Type DRUG

Standard dose of isoniazid

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

Intervention Type DRUG

High-dose isoniazid

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

Federal University of Mato Grosso

OTHER

Sponsor Role collaborator

Fiocruz Mato Grosso do Sul

UNKNOWN

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Jason Andrews

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jason R Andrews, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Federal University of Mato Grosso do Sul

Campo Grande, Mato Grosso do Sul, Brazil

Site Status

Countries

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Brazil

References

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Verma R, Patil S, Zhang N, Moreira FMF, Vitorio MT, Santos ADS, Wallace E, Gnanashanmugam D, Persing DH, Savic RM, Croda J, Andrews JR. A Rapid Pharmacogenomic Assay to Detect NAT2 Polymorphisms and Guide Isoniazid Dosing for Tuberculosis Treatment. Am J Respir Crit Care Med. 2021 Dec 1;204(11):1317-1326. doi: 10.1164/rccm.202103-0564OC.

Reference Type BACKGROUND
PMID: 34375564 (View on PubMed)

Other Identifiers

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1R21AI172182-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

65808

Identifier Type: -

Identifier Source: org_study_id