[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pediatric-hiv-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pediatric-hiv-infection":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100444611","phase-1-dolutegravir-pharmacokinetics-among-hivtb-coinfected-children-receiving-standard-and-high-dose-rifampicin-100444611",false,"NCT05069688","Dolutegravir Pharmacokinetics Among HIV\u002FTB Coinfected Children Receiving Standard and High-dose Rifampicin","Mind the Gaps: Pharmacokinetic Research to Advance Pediatric HIV\u002FTB Cotreatment and TB Prevention","Inclusion Criteria:\n\n* ART-naïve or ART-experienced HIV-infected children between 4 weeks and \\\u003C6 years of age\n* Active TB diagnosis\n* Weight of at least 3 kilograms\n* Consent of the parent or legal guardian\n\nExclusion Criteria:\n\n* Baseline labs with evidence of ≥grade 3 abnormalities: ALT, total bilirubin, absolute neutrophil count (ANC), platelets, or creatinine\n* Suspected TB meningitis or presenting with acute respiratory distress or decompensation\n* Receipt of a medication that has drug-drug interactions with dolutegravir or rifampicin","ALL","4 Weeks","5 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Tuberculosis (TB) is the leading cause of death among children with HIV, yet insufficient data are available on the pharmacokinetics of newer HIV\u002FTB cotreatment strategies in children. Current WHO-recommended rifampicin dosages result in low concentrations in most children, and high-dose rifampicin may improve outcomes and shorten treatment duration. Yet the impact of high-dose rifampicin on dolutegravir exposures has not been examined in children. This study aims to evaluate the safety and pharmacokinetics of dolutegravir twice daily among HIV\u002FTB coinfected children receiving standard-dose and high-dose rifampicin.",[27,28],"Pediatric HIV Infection","Tuberculosis Infection",[30,31,32],"pharmacokinetic","dolutegravir","rifampicin","RECRUITING","2025-11-25",{"date":36,"type":37},"2025-12-02","ACTUAL",{"date":39,"type":37},"2023-07-07",{"date":41,"type":21},"2026-12",{"name":43,"class":44},"Brigham and Women's Hospital","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":45},"100537746","phase-1-dolutegravir-pharmacokinetics-during-weekly-rifapentineisoniazid-for-tb-prevention-100537746","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.","11 Years",{"count":54,"type":21},25,[24],"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.",[27,58],"Latent Tuberculosis",[60,61,62],"Pediatric HIV","rifapentine","TB prevention","2024-12-19",{"date":65,"type":37},"2024-12-24",{"date":67,"type":37},"2024-11-15",{"date":69,"type":21},"2027-06",{"name":43,"class":44}]