drugset / Trial / NCT00571753
Isoniazid Dose Adjustment According to NAT2 Genotype (IDANAT2)
RandomizedParallel-groupTriple-blindTreatment
Summary
The study is conducted to compare safety and efficacy of isoniazid administered as an adjusted dose based on NAT2 (arylamine N-acetyltransferase type 2)genotype and as a standard dose. The hypothesis is that the genotype-adjusted dose is superior to the standard dose with regard to hepatotoxicity and early treatment failure, respectively, in the group of slow and rapid acetylators of NAT2.
Timeline
- Start
- 2008-06
- Primary completion
- 2011-12
- Completion
- 2012-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Isoniazid | Small molecule | 2.5 mg/kg | — |
| Comparator | Isoniazid | Small molecule | 5 mg/kg | — |
| Comparator | Isoniazid | Small molecule | 7.5 mg/kg | — |