Tuberculosis InfectionPhase 3NCT06191692
1HP Versus 3HR in the Treatment of Tuberculosis Infection in Vietnam
A Phase 3 study testing Isoniazid, Rifapentine and Rifampicin in people with Tuberculosis Infection, run by Freundeskreis Für Internationale Tuberkulosehilfe e.V at 2 sites in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis Infection
- What is being tested?
- Isoniazid, Rifapentine and Rifampicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesVietnam
- Study dates
- 1 Nov 2024to 30 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Household contacts of people with new, bacteriologically-confirmed, pulmonary, drug-susceptible TB who initiated treatment with residence in the intervention areas;
- Positive QFT-Plus or TST results (TST induration of at least 5mm)
- Agree to remain in contact and provide updated information as necessary, and have no current plans to relocate outside the designed area for the duration of the study;
- Age ≥ 18 years;
- Capable of providing signed informed consent;
- Willing to participate in the study visits and procedures
Who cannot join
- Indeterminate results on QFT-Plus;
- Clinical or radiographic suspicions or history of previous active TB;
- Known hypersensitivity or contraindication to any components of the regimens;
- Weight \<30kg;
- Acute or chronic liver failure with elevated liver enzymes or evidence of liver dysfunction such as jaundice or a history of liver failure caused by isoniazid or rifampicin; History of liver cirrhosis at any time before study entry;
- Infection with suspected or confirmed tuberculosis strains resistant to isoniazid or rifampicin;
Show all 11Show fewer
- Porphyria- Porphyrin metabolism disorder;
- Polyneuropathy (self-reported/ confirmed);
- Pregnant or planning to become pregnant within 120 days of enrollment;
- Any other severe underlying condition that would, in the opinion of the investigator, compromise the patient's safety or outcome in the trial;
- Participation in other clinical intervention trials or research protocols (participation in other studies that do not involve an intervention may be allowed, but this must be discussed and approved by the Chief Investigator).
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites
Ha Noi Lung Hospital
Hà Nội, 10000
Vietnam National Lung Hospital
Hanoi, Hanoi, 10000
About this study
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
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.
Read more
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)
Read the 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
- Main objective: Objective 1: Compare the treatment adherence and safety of the 1HP regimen and the standard 3HR regimen for TB infection treatment
- 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.
- Conditions
- Tuberculosis Infection
- Being tested
- Isoniazid, Rifapentine, Rifampicin
- Keywords
- Tuberculosis, TB preventive therapy, Tuberculosis infection, Latent TB infection, LTBI, TBI
- Medical subject headings
- Latent Tuberculosis, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsoniazidDrug
Also called INH
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
RifapentineDrug
Also called RPT
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
RifampicinDrug
Also called RIF
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
| Study group | Role | What they receive |
|---|---|---|
| 3 months of daily rifampicin plus isoniazid regimen (Arm A) | Active comparator | Participants will receive rifampicin (dosage based on their weight*, 10mg/kg/day, maximum 600mg), 300 mg of isoniazid, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day from week 1 to week 12 for a total of 90 doses.
* Weight will be monitored and dosing adjusted as needed during treatment Receives: Drug: Isoniazid; Drug: Rifampicin |
| 1 month of daily rifapentine plus isoniazid regimen (Arm B) | Experimental | Participants will receive rifapentine (dosage based on their weight* 300 mg daily for participants body weight of 30kg -\<35 kg, 450 mg daily for a weight of 35 to 45 kg, and 600 mg for a weight of \>=45 kg), 300 mg of isoniazid, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day from week 1 to week 4 for a total of 28 days.
* Weight will be monitored and dosing adjusted as needed during treatment Receives: Drug: Isoniazid; Drug: Rifapentine |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. % Adequate adherence in each arm
Adequate treatment adherence is defined as taking ≥90% of TB preventive therapy doses within the time frame. Treatment adherence will be recorded by both study schedule and programmatic adherence.
Measured: From study entry at Week 0 through up to 16 weeks of 3HR (Arm A), or up to 6 weeks of 1HP (Arm B), to be reported at the end of the trial.
Secondary outcomes (3)
The incidence rate of severe adverse events among two arms.
Severe adverse events are defined (DAIDS) as any untoward medical occurrence that, at any dose:
- Results in death
- Life-threatening
- Requires inpatient hospitalization or prolongation of existing hospitalization
- Results in persistent disability/incapacity
- Congenital anomaly/birth defect
Measured: From study entry at Week 0 through up to 16 weeks of 3HR (Arm A), or up to 6 weeks of 1HP (Arm B)
Comparison of adherence measured as the proportion of treatment taken in the regimens (1HP vs 3HR).
Measured: From study entry at Week 0 through up to 16 weeks of 3HR (Arm A), or up to 6 weeks of 1HP (Arm B)
The incidence rate of a targeted event of grade 3,4 or 5*** and one grade increase from the baseline among two arms.
Targeted event includes:
- Flu-like symptoms including weakness, fatigue, nausea, vomiting, headache, fever, aches, sweats, dizziness, shortness of breath, flushing, or chills.
- Hepatotoxicity, defined as a five-fold or greater increase in the AST/ALT level, a three-fold or greater increase with clinical symptoms, or total bilirubin level > 51.3 micromole/L.
- Peripheral neuropathy (Clinical diagnosis)
Measured: From study entry at Week 0 through up to 16 weeks of 3HR (Arm A), or up to 6 weeks of 1HP (Arm B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Nov 2024
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Why it stopped: Lack of Rifapentine
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Households will be randomized in a 1:1 ratio to the two treatment groups (1HP/3HR) using cluster randomization
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Freundeskreis Für Internationale Tuberkulosehilfe e.V
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191692
- Sponsor's protocol ID
- TBIshort
- Status last verified
- Sep 2026
- First submitted
- 20 Dec 2023
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06191692
- Acronym / sponsor ID
- TBIshort
- Conditions
- Tuberculosis Infection
- Keywords
- Tuberculosis, TB preventive therapy, Tuberculosis infection, Latent TB infection, LTBI, TBI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of Rifapentine
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Freundeskreis Für Internationale Tuberkulosehilfe e.VUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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
- Main objective: Objective 1: Compare the treatment adherence and safety of the 1HP regimen and the standard 3HR regimen for TB infection treatment
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Households will be randomized in a 1:1 ratio to the two treatment groups (1HP/3HR) using cluster randomization
| Arm | Type | Receives |
|---|---|---|
| 3 months of daily rifampicin plus isoniazid regimen (Arm A) | Active comparator | Drug: Isoniazid, Drug: RifampicinParticipants will receive rifampicin (dosage based on their weight*, 10mg/kg/day, maximum 600mg), 300 mg of isoniazid, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day from week 1 to week 12 for a total of 90 doses. * Weight will be monitored and dosing adjusted as needed during treatment |
| 1 month of daily rifapentine plus isoniazid regimen (Arm B) | Experimental | Drug: Isoniazid, Drug: RifapentineParticipants will receive rifapentine (dosage based on their weight* 300 mg daily for participants body weight of 30kg -\<35 kg, 450 mg daily for a weight of 35 to 45 kg, and 600 mg for a weight of \>=45 kg), 300 mg of isoniazid, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day from week 1 to week 4 for a total of 28 days. * Weight will be monitored and dosing adjusted as needed during treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Household contacts of people with new, bacteriologically-confirmed, pulmonary, drug-susceptible TB who initiated treatment with residence in the intervention areas;
- Positive QFT-Plus or TST results (TST induration of at least 5mm)
- Agree to remain in contact and provide updated information as necessary, and have no current plans to relocate outside the designed area for the duration of the study;
- Age ≥ 18 years;
- Capable of providing signed informed consent;
Key exclusion criteria (11 listed)
- Indeterminate results on QFT-Plus;
- Clinical or radiographic suspicions or history of previous active TB;
- Known hypersensitivity or contraindication to any components of the regimens;
- Weight \<30kg;
- Acute or chronic liver failure with elevated liver enzymes or evidence of liver dysfunction such as jaundice or a history of liver failure caused by isoniazid or rifampicin; History of liver cirrhosis at any time before study entry;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IsoniazidAlso: INHThis 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 | 1 month of daily rifapentine plus isoniazid regimen (Arm B), 3 months of daily rifampicin plus isoniazid regimen (Arm A) |
| RifapentineAlso: RPTThis 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 | 1 month of daily rifapentine plus isoniazid regimen (Arm B) |
| RifampicinAlso: RIFThis 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 | 3 months of daily rifampicin plus isoniazid regimen (Arm A) |
Primary outcome
1. % Adequate adherence in each arm
Time frame: From study entry at Week 0 through up to 16 weeks of 3HR (Arm A), or up to 6 weeks of 1HP (Arm B), to be reported at the end of the trial.
Adequate treatment adherence is defined as taking ≥90% of TB preventive therapy doses within the time frame. Treatment adherence will be recorded by both study schedule and programmatic adherence.
3 secondary outcomes
The incidence rate of severe adverse events among two arms.
Time frame: From study entry at Week 0 through up to 16 weeks of 3HR (Arm A), or up to 6 weeks of 1HP (Arm B)
Comparison of adherence measured as the proportion of treatment taken in the regimens (1HP vs 3HR).
Time frame: From study entry at Week 0 through up to 16 weeks of 3HR (Arm A), or up to 6 weeks of 1HP (Arm B)
The incidence rate of a targeted event of grade 3,4 or 5*** and one grade increase from the baseline among two arms.
Time frame: From study entry at Week 0 through up to 16 weeks of 3HR (Arm A), or up to 6 weeks of 1HP (Arm B)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Isoniazid, Rifapentine and Rifampicin in people with Tuberculosis Infection, run by Freundeskreis Für Internationale Tuberkulosehilfe e.V at 2 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. % Adequate adherence in each arm (time frame: From study entry at Week 0 through up to 16 weeks of 3HR (Arm A), or up to 6 weeks of 1HP (Arm B), to be reported at the end of the trial.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.