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1HP Versus 3HR in the Treatment of Tuberculosis Infection in Vietnam

NCT06191692 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2025-03-19

No results posted yet for this study

Summary

Introduction: Tuberculosis (TB) infection is a key driver of the TB pandemic, with over 10.6 million people fell ill with TB disease in 2022. About one-quarter of the global population is estimated to be infected with TB bacteria. Around 5-10% of people with TB infection will develop active and contagious TB disease, which could be largely avoided if TB infection is identified and given effective preventative treatment, before progression to active disease. The long treatment of TB infection with regimens lasting from three to nine months is a significant barrier to treatment completion in individuals with a confirmed diagnosis of TB infection. Adapting a shorter regimen than the current regimens could lead to a higher treatment completion rate and increased uptake of preventative therapy for TB, as well as reduced side effects.

Methods and analysis: An open-label, randomized clinical trial (1:1) will be performed in two study sites in Ha Noi, Vietnam (Vietnam National Lung Hospital and Ha Noi Lung Hospital). Adult household contacts (n=350) of people with new, bacteriologically-confirmed, pulmonary, drug-susceptible TB who initiate treatment will be invited to participate.

Aim: To compare the TB preventive therapy completion rates and adverse event incidence between a new one-month regimen (1HP) versus the current three-month regimen (3HR)\*.

\*1HP= one month of daily isoniazid (H/INH) and rifapentine (P/RPT) 3HR= three months of daily isoniazid (H/INH) and rifampicin (R/RIF)

Conditions

  • Tuberculosis Infection

Interventions

DRUG

Isoniazid

This randomized control trial will compare the treatment adherence and safety of the 1HP (Arm B) regimen and standard 3HR (Arm A) regimens for TB infection treatment

DRUG

Rifapentine

This randomized control trial will compare the treatment adherence and safety of the 1HP (Arm B) regimen and standard 3HR (Arm A) regimens for TB infection treatment

DRUG

Rifampicin

This randomized control trial will compare the treatment adherence and safety of the 1HP (Arm B) regimen and standard 3HR (Arm A) regimens for TB infection treatment

Sponsors & Collaborators

  • Freundeskreis Für Internationale Tuberkulosehilfe e.V

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2026-12-01
Completion
2027-12-01

Countries

  • Vietnam

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 NCT06191692 on ClinicalTrials.gov