[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100448364":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":28,"centralContacts":11,"locations":33,"responsibleParty":82,"collaborators":84,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":11,"enrollmentInfo":97,"targetDuration":11,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":108,"overallStatus":112,"whyStopped":11,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"The Aurum Institute NPC","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: People living with HIV infection without active TB","EXPERIMENTAL",null,[13,14],"Drug: Daily rifapentine and isoniazid for 4 weeks","Drug: Weekly rifapentine and isoniazid for 12 weeks",{"label":16,"type":10,"description":11,"interventionNames":17},"Group 2: HIV-negative household contacts of adults with rifampicin-sensitive pulmonary TB",[13,14],[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","Daily rifapentine and isoniazid for 4 weeks","Arm A: isoniazid (300mg) and rifapentine (600mg) daily for 4 weeks (1HP)",[9,16],{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Weekly rifapentine and isoniazid for 12 weeks","Arm B: isoniazid (900mg) and rifapentine (900mg) weekly for 12 weeks (3HP)",[9,16],[29],{"name":30,"affiliation":31,"role":32},"Gavin Churchyard","Aurum Institute","STUDY_CHAIR",[34,47,59,70],{"facility":35,"status":11,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":11},"The Byramjee Jeejeebhoy Medical Centre (BJGMC-JHU) CRS","Pune","Maharashtra","411001","India","IN",{"type":42,"coordinates":43},"Point",[44,45],73.85535,18.51957,{"lat":45,"lon":44},{"facility":48,"status":11,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":58,"contacts":11},"Yayasan KNCV - The Persahabatan Hospital, Jakarta","Jakarta","Jaya","14350","Indonesia","ID",{"type":42,"coordinates":55},[56,57],106.84513,-6.21462,{"lat":57,"lon":56},{"facility":60,"status":11,"city":61,"state":62,"zip":11,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":69,"contacts":11},"Fundação Aurum (The Aurum Institute Mozambique)","Chokwé","Gaza Province","Mozambique","MZ",{"type":42,"coordinates":66},[67,68],32.98333,-24.53333,{"lat":68,"lon":67},{"facility":71,"status":11,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":81,"contacts":11},"The Aurum Institute: Gavin J Churchyard Legacy Centre","Klerksdorp","North West","2571","South Africa","ZA",{"type":42,"coordinates":78},[79,80],26.66672,-26.85213,{"lat":80,"lon":79},{"type":83,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[85],{"name":86,"class":6},"Johns Hopkins University","100448364","phase-4-comparing-treatment-completion-of-daily-rifapentine--isoniazid-for-one-month-1hp-to-weekly-high-dose-rifapentine--isoniazid-for-3-months-3hp-in-persons-living-with-hiv-and-in-household-contacts-of-recently-diagnosed-tuberculosis-patients-100448364",false,"NCT05118490","Comparing Treatment Completion Of Daily Rifapentine & Isoniazid For One Month (1HP) To Weekly High Dose Rifapentine & Isoniazid For 3 Months (3HP) In Persons Living With HIV and in Household Contacts of Recently Diagnosed Tuberculosis Patients","A Randomized Trial Comparing Treatment Completion of Daily Rifapentine & Isoniazid for One Month (1HP) To Weekly Rifapentine & Isoniazid For 3 Months (3HP) In Persons Living With HIV and in HIV-negative Household Contacts of Recently Diagnosed Tuberculosis Patients, The \"One To Three\" Trial","1 to 3","Group 1: HIV-positive adolescents and adults in South Africa and India\n\nInclusion criteria:\n\n1. Age ≥ 13 years\n2. Weight \\> 30 kg\n3. HIV-seropositive\n4. HIV viral load \\\u003C400 copies\u002FmL, defined as \"virally suppressed,\" on an EFV or DTG-based ART regimen (see Section 3.6.2)\n5. Candidates must meet WHO criteria for receiving TPT\n\nExclusion criteria:\n\n1. Confirmed or suspected TB disease (evidenced by symptoms and\u002For clinical exam findings and\u002For chest radiographic findings suggestive of TB, positive mycobacterial culture or molecular TB testing or currently on TB treatment for active TB disease)\n2. Likely to move from the study area during the study period\n3. Known recent exposure to a TB case with resistance to isoniazid or rifampicin.\n4. Previous treatment for active or latent TB for more than 30 days within the past 2 years\n5. On nevirapine, etravirine, rilpivirine, PI-based, or raltegravir-containing ART regimens\n6. Known sensitivity or intolerance to isoniazid or rifamycins\n7. Suspected acute hepatitis or known chronic or unstable liver disease\\^\n8. ALT \\> 3 times the upper limit of normal (ULN)\n9. Total bilirubin \\> 2.5 times the ULN\n10. Pregnancy or breastfeeding Females of childbearing potential who are unable or unwilling to use two forms of contraception\\*\\*\n11. On prohibited medications (see Appendix I)\n\nGroup 2: HIV-negative household contacts of an adult with confirmed pulmonary TB in Mozambique and Indonesia\n\nInclusion criteria:\n\n1. Age ≥ 13 years\n2. Weight \\> 30 kg\n3. HIV-negative\n4. Household contact of an adult with confirmed rifampicin-sensitive pulmonary TB\n5. Candidates must meet WHO criteria for receiving TPT\n\nExclusion criteria:\n\n1. Confirmed or suspected TB disease (evidenced by symptoms and\u002For clinical exam findings and\u002For chest radiographic findings suggestive of TB, positive mycobacterial culture or molecular TB testing or currently on TB treatment for active TB disease)\n2. Likely to move from the study area during the study period\n3. Known exposure to TB cases with resistance to isoniazid or rifampicin in the source case\n4. Previous treatment for active or latent TB for \\>30 days within the past 2 years\n5. Known sensitivity or intolerance to isoniazid or rifamycins\n6. Suspected acute hepatitis or known chronic or unstable liver disease\\^\n7. ALT \\> 3 times the upper limit of normal (ULN)\n8. Total bilirubin \\> 2.5 times the ULN\n9. Pregnancy or breastfeeding Females of childbearing potential who are unable or unwilling to use two forms of contraception\\*\\*\n10. On prohibited medications","ALL","13 Years",{"count":98,"type":99},1000,"ESTIMATED","INTERVENTIONAL",[102],"PHASE4","A multicenter, randomized, stratified, open-label, phase IV trial among HIV-positive persons (PLHIV) on antiretroviral therapy (ART), or HIV-negative household contacts of patients with rifampicin-sensitive pulmonary tuberculosis (TB), who do not have evidence of active TB.",[105,106,107],"HIV Seropositivity","Tuberculosis","Household Contact",[109,110,111],"Tuberculosis preventive treatment","rifapentine","HIV uninfected","ACTIVE_NOT_RECRUITING","2025-12-05",{"date":115,"type":116},"2025-12-12","ACTUAL",{"date":118,"type":116},"2023-07-19",{"date":120,"type":99},"2025-12-31",{"name":5,"class":6},4]