Pharmacokinetics of rifapentine and isoniazid and NAT2 and SLCO1B1 polymorphisms in pediatric Thai patients with latent tuberculosis infectio

Phase 4

• Conditions: Pediatric Thai patients with latent tuberculosis infection; rifapentine, isoniazid, pharmacokinetics, pediatric, latent tuberculosis infection

• Registration Number: TCTR20190423002
• Lead Sponsor: submitted proposal for HSRI funding of tuberculosis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-23
• Study Completion: 2020-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

-Male or female aged 2-18 years
-Newly diagnosed LTBI patients 
-Informed consent

Exclusion Criteria

-Body weight <10 kg
-Acute hepatitis

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mean Tmax, Cmax, AUC of rifapentine and isoniazid 0, 1, 2, 4, 6, 8, 12, and 24 hours HPLC, LCMS

Secondary Outcome Measures

Name	Time	Method
genotype variants of NAT2 and SLCO1B1 predose (0 hour) Real-time PCR