[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530815":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":39,"centralContacts":40,"locations":46,"responsibleParty":77,"collaborators":39,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":39,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":39,"enrollmentInfo":88,"targetDuration":39,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":104,"whyStopped":39,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Freundeskreis Für Internationale Tuberkulosehilfe e.V","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"3 months of daily rifampicin plus isoniazid regimen (Arm A)","ACTIVE_COMPARATOR","Participants will receive rifampicin (dosage based on their weight\\*, 10mg\u002Fkg\u002Fday, 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.\n\n\\* Weight will be monitored and dosing adjusted as needed during treatment",[13,14],"Drug: Isoniazid","Drug: Rifampicin",{"label":16,"type":17,"description":18,"interventionNames":19},"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.\n\n\\* Weight will be monitored and dosing adjusted as needed during treatment",[13,20],"Drug: Rifapentine",[22,29,34],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"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",[16,9],[28],"INH",{"type":23,"name":30,"description":25,"armGroupLabels":31,"otherNames":32},"Rifapentine",[16],[33],"RPT",{"type":23,"name":35,"description":25,"armGroupLabels":36,"otherNames":37},"Rifampicin",[9],[38],"RIF",null,[41],{"name":42,"role":43,"phone":44,"phoneExt":39,"email":45},"Han Nguyen, MD","CONTACT","+ 84945421868","han.nguyen@tbhelp.org",[47,65],{"facility":48,"status":39,"city":49,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Vietnam National Lung Hospital","Hanoi","10000","Vietnam","VN",{"type":54,"coordinates":55},"Point",[56,57],105.84117,21.0245,{"lat":57,"lon":56},[60,62],{"name":42,"role":43,"phone":61,"phoneExt":39,"email":45},"+84945421868",{"name":63,"role":64,"phone":39,"phoneExt":39,"email":39},"Luong Van Dinh, MD, PhD","PRINCIPAL_INVESTIGATOR",{"facility":66,"status":39,"city":67,"state":39,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Ha Noi Lung Hospital","Hà Nội",{"type":54,"coordinates":69},[70,71],106.02292,20.47366,{"lat":71,"lon":70},[74,75],{"name":42,"role":43,"phone":61,"phoneExt":39,"email":45},{"name":76,"role":64,"phone":39,"phoneExt":39,"email":39},"Dong Van Nguyen, MD",{"type":78,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100530815","phase-3-1hp-versus-3hr-in-the-treatment-of-tuberculosis-infection-in-vietnam-100530815",false,"NCT06191692","1HP Versus 3HR in the Treatment of Tuberculosis Infection in Vietnam","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","Inclusion Criteria:\n\n* Household contacts of people with new, bacteriologically-confirmed, pulmonary, drug-susceptible TB who initiated treatment with residence in the intervention areas;\n* Positive QFT-Plus or TST results (TST induration of at least 5mm)\n* 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;\n* Age ≥ 18 years;\n* Capable of providing signed informed consent;\n* Willing to participate in the study visits and procedures\n\nExclusion Criteria:\n\n* Indeterminate results on QFT-Plus;\n* Clinical or radiographic suspicions or history of previous active TB;\n* Known hypersensitivity or contraindication to any components of the regimens;\n* Weight \\<30kg;\n* 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;\n* Infection with suspected or confirmed tuberculosis strains resistant to isoniazid or rifampicin;\n* Porphyria- Porphyrin metabolism disorder;\n* Polyneuropathy (self-reported\u002F confirmed);\n* Pregnant or planning to become pregnant within 120 days of enrollment;\n* Any other severe underlying condition that would, in the opinion of the investigator, compromise the patient's safety or outcome in the trial;\n* 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).","ALL","18 Years",{"count":89,"type":90},350,"ESTIMATED","INTERVENTIONAL",[93],"PHASE3","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.\n\nMethods 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.\n\nAim: 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)\\*.\n\n\\*1HP= one month of daily isoniazid (H\u002FINH) and rifapentine (P\u002FRPT) 3HR= three months of daily isoniazid (H\u002FINH) and rifampicin (R\u002FRIF)",[96],"Tuberculosis Infection",[98,99,100,101,102,103],"Tuberculosis","TB preventive therapy","Tuberculosis infection","Latent TB infection","LTBI","TBI","NOT_YET_RECRUITING","2025-03-17",{"date":107,"type":108},"2025-03-19","ACTUAL",{"date":110,"type":90},"2025-08-01",{"date":112,"type":90},"2027-12-01",{"name":5,"class":6},2]