Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-01-25 @ 8:30 AM
Study NCT ID:
NCT06191692
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-19
First Post:
2023-12-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
1HP Versus 3HR in the Treatment of Tuberculosis Infection in Vietnam
Sponsor:
Freundeskreis Für Internationale Tuberkulosehilfe e.V
Organization:
Study Overview
Official Title:
An Open-label, Randomized Controlled Trial of the New One-month Regimen Versus the Current Three-month Regimen for the Treatment of Tuberculosis Infection in Vietnam
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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)
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)
Detailed Description:
Latent TB infection, hereafter referred to as TB infection, is a key driver of the TB pandemic. Over 10.6 million people developed active TB in 2022 and about one-quarter of the global population is estimated to be infected with TB bacteria, meaning approximately two billion people are affected worldwide. On average, 5-10% of people with TB infection will develop active TB, usually within the first five years after their initial TB infection. Therefore, preventative treatment is a fundamental component of a comprehensive strategy to end TB.
The current duration of TB Prevention Treatment (TPT), which lasts from three to nine months, is a significant barrier resulting in the low uptake of the TPT.
A one-month TPT regimen using two drugs (isoniazid and rifapentine, 1HP) was proven effective and had higher completion rates for people living with HIV; however, the initial demonstration trial was not performed in a cohort of people without HIV. The use of a shorter TPT regimen than the current three-month TPT regimen could lead to higher completion rates and increased uptake among a large number of individuals in need of TPT. Moreover, it may potentially reduce adverse events as well as decrease the medical and non-medical costs associated with the TPT.
Therefore, the investigators propose a comprehensive study of shortened TPT for TB infection in Vietnam, a low HIV burden setting.
An open-label, randomized controlled trial (TBIshort) of the new one-month TPT regimen versus the current three-month regimen for the treatment of TB infection in Vietnam will be performed and funded by Stop TB Partnership's TB REACH initiative to compare treatment completion rate and safety between the two regimens. Households will be randomized in a 1:1 ratio to the two arms using cluster randomization. All participants from the same household will be allocated to the same treatment regimen arm. The proposed study will address key knowledge gaps, and provide objective evidence to guide decision-making for the use of the 1HP regimen for the treatment of TB infection in a low HIV burden setting.
Aims
1. Main objective:
Objective 1: Compare the treatment adherence and safety of the 1HP regimen and the standard 3HR regimen for TB infection treatment
2. Specific objectives:
Objective 2: Compare the treatment completion rates for TB infection between 1HP and 3HR regimens.
Objective 3: Compare adverse events incidence for 1HP and 3HR regimens during three months from treatment start.
The current duration of TB Prevention Treatment (TPT), which lasts from three to nine months, is a significant barrier resulting in the low uptake of the TPT.
A one-month TPT regimen using two drugs (isoniazid and rifapentine, 1HP) was proven effective and had higher completion rates for people living with HIV; however, the initial demonstration trial was not performed in a cohort of people without HIV. The use of a shorter TPT regimen than the current three-month TPT regimen could lead to higher completion rates and increased uptake among a large number of individuals in need of TPT. Moreover, it may potentially reduce adverse events as well as decrease the medical and non-medical costs associated with the TPT.
Therefore, the investigators propose a comprehensive study of shortened TPT for TB infection in Vietnam, a low HIV burden setting.
An open-label, randomized controlled trial (TBIshort) of the new one-month TPT regimen versus the current three-month regimen for the treatment of TB infection in Vietnam will be performed and funded by Stop TB Partnership's TB REACH initiative to compare treatment completion rate and safety between the two regimens. Households will be randomized in a 1:1 ratio to the two arms using cluster randomization. All participants from the same household will be allocated to the same treatment regimen arm. The proposed study will address key knowledge gaps, and provide objective evidence to guide decision-making for the use of the 1HP regimen for the treatment of TB infection in a low HIV burden setting.
Aims
1. Main objective:
Objective 1: Compare the treatment adherence and safety of the 1HP regimen and the standard 3HR regimen for TB infection treatment
2. Specific objectives:
Objective 2: Compare the treatment completion rates for TB infection between 1HP and 3HR regimens.
Objective 3: Compare adverse events incidence for 1HP and 3HR regimens during three months from treatment start.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: