Last reviewed · How we verify
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)
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.
Details
| Lead sponsor | The HIV Netherlands Australia Thailand Research Collaboration |
|---|---|
| Phase | Phase 3 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 2500 |
| Start date | 2019-08-15 |
| Completion | 2038-03 |
Conditions
- HIV-infected Participants With Latent TB Infection in High TB Burden Country
Interventions
- Isoniazid/Rifapentine daily (4 weeks) plus pyridoxine (vitamin B6)
- Isoniazid/Rifapentine 12-weekly plus pyridoxine (vitamin B6)
Primary outcomes
- efficacy in preventing active TB (proportion of participants that do not have active TB by the end of the study) — 3 years
proportion of participants that do not have active TB by the end of the study - safety of the regimens (proportion of participants that do not have any side effects throughout the study period) — 3 years
proportion of participants that do not have any side effects throughout the study period - tolerability to the regimens (proportion of participants that can complete the treatment course) — 3 years
proportion of participants that can complete the treatment course - prevalence of drug resistance of MTB — 3 years
proportion of participants with drug resistance to MTB
Countries
Thailand