[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100444611":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":47,"collaborators":50,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":20,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":20,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Brigham and Women's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Dolutegravir PK during standard and high-dose rifampicin","EXPERIMENTAL","This is a single arm study: all patients are started on HIV\u002FTB cotreatment considered standard of care and then for two weeks (study weeks 20-21) high-dose rifampicin is given during which safety and pharmacokinetics are examined.",[13],"Drug: rifampicin",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","rifampicin","Patients will receive standard TB and HIV treatment, however, for two weeks (study weeks 20-21) the dose of rifampicin will be increased from standard-dose to high-dose to assess pharmacokinetics and safety",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Holly Rawizza, MD, MPH","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","617-432-4686","hrawizza@bwh.harvard.edu",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":20,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"University College Hospital\u002F University of Ibadan","RECRUITING","Ibadan","Oyo State","Nigeria","NG",{"type":39,"coordinates":40},"Point",[41,42],3.90591,7.37756,{"lat":42,"lon":41},[45],{"name":46,"role":27,"phone":20,"phoneExt":20,"email":20},"Regina Oladokun, MD",{"type":24,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Holly Rawizza, M.D., M.P.H.","Assistant Professor of Medicine",[51,54],{"name":52,"class":53},"APIN Public Health Initiatives","UNKNOWN",{"name":55,"class":6},"University of Cape Town","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":67,"type":68},20,"ESTIMATED","INTERVENTIONAL",[71],"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.",[74,75],"Pediatric HIV Infection","Tuberculosis Infection",[77,78,17],"pharmacokinetic","dolutegravir","2025-11-25",{"date":81,"type":82},"2025-12-02","ACTUAL",{"date":84,"type":82},"2023-07-07",{"date":86,"type":68},"2026-12",{"name":5,"class":6},1]