NCT03785106

Tuberculosis Preventive Therapy Among Latent Tuberculosis Infection in HIV-infected Individuals

Implementation for Tuberculosis Preventive Therapy Among Latent Tuberculosis Infection in HIV-infected Individuals Using Novel Regimen of Isoniazid/Rifapentine Daily (4 Weeks) Compared to Isoniazid/Rifapentine Weekly (12 Weeks)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,500 (actual)
• Sponsor: The HIV Netherlands Australia Thailand Research Collaboration · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators want to know if ultra-short, effective treatment for latent tuberculosis (TB) infection (LTBI) could dramatically reduce the global incidence of active TB or not. The investigators hypothesize that short-course (4-week) daily isoniazid/rifapentine (INH/RPT) (1HP) is not inferior to standard -course (12 weeks) INH/RPT weekly regimen (3HP) for the prevention of TB in human immunodeficiency virus (HIV)-infected individuals.

Detailed description

This study is a multicenter, randomized, open-label, phase III clinical trial comparing a 4-week daily INH/RPT regimen (1HP) to a 12-weekly INH/RPT (3HP) for the treatment of LTBI in HIV-infected participants without evidence of active TB. The primary objective will be efficacy of active TB prevention. The study will also assess safety and tolerability of the regimens, adherence to the treatments, and patterns of antibiotic resistance among Mycobacterium tuberculosis (MTB) isolates in participants who fail on these prophylactic regimens. Under this study, there is one substudy entitled, "Pharmacokinetic study of rifapentine, dolutegravir, and tenofovir alafenamide in HIV-infected individual with latent tubersulosis infection". There will be a subgroup of patients who will participate in this pharmacokinetic study of rifapentine and dolutegravir (DTG) / tenofovir alafenamide (TAF). Randomization is based on cluster of differentiation 4 (CD4) categories : \< 200, 200-350, \> 500 cells/mm3 and VL \<50 or \>50 copies/ml.

Conditions

• HIV-infected Participants With Latent TB Infection in High TB Burden Country

Interventions

Type	Name	Description
DRUG	Isoniazid/Rifapentine daily (4 weeks) plus pyridoxine (vitamin B6)	Isoniazid/Rifapentine daily (4 weeks) plus pyridoxine (vitamin B6)
DRUG	Isoniazid/Rifapentine 12-weekly plus pyridoxine (vitamin B6)	Isoniazid/Rifapentine 12-weekly plus pyridoxine (vitamin B6)

Timeline

• Start date: 2019-08-15
• Primary completion: 2038-03-01
• Completion: 2038-03-01
• First posted: 2018-12-24
• Last updated: 2025-03-17

Locations

16 sites across 1 country: Thailand