[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537746":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":30,"locations":35,"responsibleParty":54,"collaborators":57,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":21,"eligibilityCriteria":68,"healthyVolunteers":65,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":21,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":38,"whyStopped":21,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Brigham and Women's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Dolutegravir PK during weekly rifapentine\u002Fisoniazid for TB prevention","EXPERIMENTAL","This is a single arm study: all patients are started on standard HIV treatment, with LTBI\u002FTB prevention treatment varying according to age cohorts. Children 2-11 years receive standard weekly rifapentine\u002Fisoniazid (3HP) for TB prevention; those \\\u003C2 years received a single-dose of extrapolated weekly RPT\u002FINH, followed by standard INH prophylaxis.",[13,14],"Drug: Rifapentine","Drug: Dolutegravir",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Rifapentine","Children 2-11 years received standard HIV treatment and 3HP (RPT\u002FINH weekly for 12 weeks) for TB prevention. Children \\\u003C2 years receive standard HIV treatment, a single-dose of extrapolated weekly RPT\u002FINH, followed by standard INH prophylaxis. Safety and pharmacokinetics will be evaluated.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Dolutegravir","All children in this study are living with HIV and thus dolutegravir is a standard part of treatment; in this study we will collect blood samples to measure dolutegravir levels during combination treatment with rifapentine\u002Fisoniazid treatment for TB prevention",[9],[27],{"name":28,"affiliation":5,"role":29},"Holly Rawizza, MD, MPH","PRINCIPAL_INVESTIGATOR",[31],{"name":28,"role":32,"phone":33,"phoneExt":21,"email":34},"CONTACT","617-432-4686","hrawizza@bwh.harvard.edu",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"University College Hospital","RECRUITING","Ibadan","Oyo State","Nigeria","NG",{"type":44,"coordinates":45},"Point",[46,47],3.90591,7.37756,{"lat":47,"lon":46},[50],{"name":51,"role":32,"phone":52,"phoneExt":21,"email":53},"Regina Oladokun, MD","16172305959","ginaolad@gmail.com",{"type":29,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Holly Rawizza, M.D., M.P.H.","Assistant Professor of Medicine",[58,61],{"name":59,"class":60},"APIN Public Health Initiatives","UNKNOWN",{"name":62,"class":6},"University of Cape Town","100537746","phase-1-dolutegravir-pharmacokinetics-during-weekly-rifapentineisoniazid-for-tb-prevention-100537746",false,"NCT06281834","Dolutegravir Pharmacokinetics During Weekly Rifapentine\u002FIsoniazid for TB Prevention","Inclusion Criteria:\n\n* (1) ART-naïve or ART-experienced HIV-infected children 4 weeks to \\\u003C12 years of age;\n* (2) no evidence of active TB based on an appropriate clinical evaluation;\n* (3) negative TB diagnostic test if performed (other than tuberculin skin testing);\n* (4) weight of at least 4 kilograms; and\n* (5) consent of the parent or legal guardian and assent of the child (if ≥7 years of age).\n\nExclusion Criteria:\n\n* (1) Baseline labs with evidence of ≥grade 3 abnormalities: alanine aminotransferase (ALT), total bilirubin, absolute neutrophil count (ANC), platelets, creatinine;\n* (2) presenting with acute respiratory distress or decompensation, or any clinical syndrome which could suggest undiagnosed TB or other opportunistic infection; or\n* (3) receipt of a medication that has drug-drug interactions with DTG or RPT.","ALL","4 Weeks","11 Years",{"count":73,"type":74},25,"ESTIMATED","INTERVENTIONAL",[77],"PHASE1","Tuberculosis (TB) is the leading cause of death among children living with HIV, yet insufficient data are available on the pharmacokinetics of newer TB prevention strategies in children. Short-course TB prevention\u002Flatent TB infection (LTBI) treatment regimens increase completion rates but have not been adequately studied among children living with HIV. Our prospective, open-label PK study will examine and extend use of weekly rifapentine and isoniazid (3HP) among children receiving dolutegravir. This will address gaps in knowledge by examining two-way PK of short-course LTBI treatment in a vulnerable pediatric population.",[80,81],"Pediatric HIV Infection","Latent Tuberculosis",[83,84,85],"Pediatric HIV","rifapentine","TB prevention","2024-12-19",{"date":88,"type":89},"2024-12-24","ACTUAL",{"date":91,"type":89},"2024-11-15",{"date":93,"type":74},"2027-06",{"name":5,"class":6},1]