1HP Versus 3HR in the Treatment of Tuberculosis Infection in Vietnam
Status:
Not yet recruiting
Trial end date:
2026-12-01
Target enrollment:
Participant gender:
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)
Phase:
Phase 3
Details
Lead Sponsor:
Freundeskreis Für Internationale Tuberkulosehilfe e.V