CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 78 enrolled / 78 target
Drug / intervention
Low-dose isoniazid +2 moredrug
Likely dose
Low-dose isoniazid 5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05413551
NCT05413551Phase 1CompletedHigh Momentum (2.0/mo)Completion was 14mo ago
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Point-of-care Pharmacogenomic Testing to Optimize Isoniazid Dosing for Tuberculosis Prevention

Stanford University·interventional·Posted Jun 10, 2022·Updated Jun 15, 2026

In Brief

A Phase 1 clinical trial evaluating Low-dose isoniazid, Standard dose of isoniazid, and 1 other intervention for Tuberculosis Infection and Isoniazid Adverse Reaction. Completed, enrolled 78 participants across 1 site.

Signals

Enrolling ahead of pace

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis Infection, Isoniazid Adverse Reaction
CountriesBrazil
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID), Federal University of Mato Grosso, Fiocruz Mato Grosso do Sul

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedJun 10, 2022
Enrollment StartMar 23, 2023
Primary CompletionApr 23, 2025
Study CompletionJun 25, 2025
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 4.1 years ago

Arms & Interventions

Rapid acetylatorexperimental

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

Drug: Standard dose of isoniazidDrug: High-dose isoniazid
Intermediate acetylatoractive_comparator

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

Drug: Standard dose of isoniazid
Slow acetylatorexperimental

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

Drug: Low-dose isoniazidDrug: Standard dose of isoniazid

Interventions

Low-dose isoniaziddrug

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

Standard dose of isoniaziddrug

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

High-dose isoniaziddrug

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