Tuberculosis Preventive Therapy Among Latent Tuberculosis Infection in HIV-infected Individuals
NCT03785106 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2500
Last updated 2025-03-17
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.
Conditions
- HIV-infected Participants With Latent TB Infection in High TB Burden Country
Interventions
- 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)
Sponsors & Collaborators
-
King Chulalongkorn Memorial Hospital
collaborator OTHER -
Police General Hospital
collaborator OTHER -
Pranangklao Hospital
collaborator UNKNOWN -
Taksin Hospital
collaborator UNKNOWN -
Bhumibol Adulyadej Hospital
collaborator OTHER -
Klang Hospital
collaborator UNKNOWN -
Chiang Rai Prachanukroh Hospital
collaborator UNKNOWN -
Sanpatong Hospital
collaborator UNKNOWN -
Queen Sawang Vadhana Memorial Hospital
collaborator UNKNOWN -
Buddhachinnaraj Hospital
collaborator UNKNOWN -
Maharat Nakhon Ratchasima Hospital
collaborator OTHER -
HatYai Hospital
collaborator OTHER -
Srinagarind Hospital, Khon Kaen University
collaborator OTHER -
Sisaket Hospital
collaborator UNKNOWN -
The Public Health Centre 28 Krung thon buri
collaborator UNKNOWN -
The HIV Netherlands Australia Thailand Research Collaboration
lead OTHER
Principal Investigators
-
Anchalee Avihingsanon, MD, PhD · HIV-NAT, Thai Red Cross - AIDS Research Centre
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-08-15
- Primary Completion
- 2038-03-31
- Completion
- 2038-03-31
Countries
- Thailand
Study Locations
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