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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03785106 on ClinicalTrials.gov