Optimizing isoniazid dosing for tuberculosis prevention using genetic testing
Official title: Point-of-care Pharmacogenomic Testing to Optimize Isoniazid Dosing for Tuberculosis Prevention
Run by Stanford University · NCT05413551 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study tests if giving the right dose of a tuberculosis prevention drug based on a person's genes can help keep them healthier and avoid side effects.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 72 (estimated) |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Campo Grande, Mato Grosso do Sul) |
| Trial ID | NCT05413551 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals eligible for latent tuberculosis treatment as per Brazil's national guidelines.
✕Probably not a fit
Patients with active tuberculosis or those who have contraindications to isoniazid will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial aims to evaluate whether adjusting the dose of isoniazid based on an individual's NAT2 genotype can enhance the effectiveness of tuberculosis prevention. Participants will receive either low, standard, or high doses of isoniazid to determine the optimal dosing strategy. The study focuses on individuals eligible for latent tuberculosis treatment according to Brazil's national guidelines. By personalizing treatment based on genetic factors, the trial seeks to improve patient outcomes and reduce adverse reactions.
Why it matters
Potential benefit: If successful, this approach could lead to more effective tuberculosis prevention with fewer side effects for patients.
How similar studies have gone: Similar pharmacogenomic approaches have shown promise in optimizing drug dosing in other conditions, suggesting potential success for this novel application.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Federal University of Mato Grosso do Sul
Campo Grande, Mato Grosso do Sul, Brazil Recruiting
Study contacts
- Principal investigator: Jason R Andrews, MD — Stanford University
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.