[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100147864":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":167,"collaborators":169,"id":175,"slug":176,"hasResults":177,"nctId":178,"briefTitle":179,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":177,"sex":182,"minAge":26,"maxAge":183,"enrollmentInfo":184,"targetDuration":26,"studyType":187,"phases":188,"briefSummary":191,"conditions":192,"keywords":194,"overallStatus":198,"whyStopped":26,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":208},{"fullName":5,"class":6},"PENTA Foundation","NETWORK",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"QD kaletra","EXPERIMENTAL","Once daily kaletra",[13],"Drug: Kaletra dosed once daily",{"label":15,"type":16,"description":17,"interventionNames":18},"BID kaletra","ACTIVE_COMPARATOR","twice daily dose of kaletra",[19],"Drug: kaletra dosed twice daily",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Kaletra dosed once daily","Lopinavir\u002FRitonavir tablets. Dose = 200\u002F50mg or 100\u002F25mg. Frequency = once daily.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"kaletra dosed twice daily","Lopinavir\u002FRitonavir tablets. Dose = 200\u002F50mg or 100\u002F25mg. Frequency = twice daily.",[15],[32,43,51,59,67,77,87,95,102,110,120,128,136,141,146,151,159],{"facility":33,"status":26,"city":34,"state":26,"zip":26,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":26},"Charite University Hospital Berlin","Berlin","Germany","DE",{"type":38,"coordinates":39},"Point",[40,41],13.41053,52.52437,{"lat":41,"lon":40},{"facility":44,"status":26,"city":45,"state":26,"zip":26,"country":35,"countryCode":36,"cosmosGeoPoint":46,"geoPoint":50,"contacts":26},"Department of Pediatric Oncology Hematology and Immunology KA02","Düsseldorf",{"type":38,"coordinates":47},[48,49],6.77927,51.22319,{"lat":49,"lon":48},{"facility":52,"status":26,"city":53,"state":26,"zip":26,"country":35,"countryCode":36,"cosmosGeoPoint":54,"geoPoint":58,"contacts":26},"J W Goethe University","Frankfurt",{"type":38,"coordinates":55},[56,57],10.53333,49.68333,{"lat":57,"lon":56},{"facility":60,"status":26,"city":61,"state":26,"zip":26,"country":35,"countryCode":36,"cosmosGeoPoint":62,"geoPoint":66,"contacts":26},"Immundefekt-Ambulanz, Dr. von Haunersches Kinderspital","Munich",{"type":38,"coordinates":63},[64,65],11.57549,48.13743,{"lat":65,"lon":64},{"facility":68,"status":26,"city":69,"state":26,"zip":26,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":76,"contacts":26},"Our Lady's Children's Hospital","Dublin","Ireland","IE",{"type":38,"coordinates":73},[74,75],-6.24889,53.33306,{"lat":75,"lon":74},{"facility":78,"status":26,"city":79,"state":26,"zip":26,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":86,"contacts":26},"Emma Childrens Hospital","Amsterdam","Netherlands","NL",{"type":38,"coordinates":83},[84,85],4.88969,52.37403,{"lat":85,"lon":84},{"facility":88,"status":26,"city":89,"state":26,"zip":26,"country":80,"countryCode":81,"cosmosGeoPoint":90,"geoPoint":94,"contacts":26},"UMC St. Radboud","Nijmegen",{"type":38,"coordinates":91},[92,93],5.85278,51.8425,{"lat":93,"lon":92},{"facility":96,"status":26,"city":97,"state":98,"zip":99,"country":100,"countryCode":101,"cosmosGeoPoint":26,"geoPoint":26,"contacts":26},"Program for HIV Prevention and Treatment (PHPT)\u002FIRD 174","Changklan, Muang","Chiang Mai","50100","Thailand","TH",{"facility":103,"status":26,"city":104,"state":26,"zip":26,"country":100,"countryCode":101,"cosmosGeoPoint":105,"geoPoint":109,"contacts":26},"HIV-NAT Thai Red Cross AIDS Research Centre","Bangkok",{"type":38,"coordinates":106},[107,108],100.50144,13.75398,{"lat":108,"lon":107},{"facility":111,"status":26,"city":112,"state":26,"zip":26,"country":113,"countryCode":114,"cosmosGeoPoint":115,"geoPoint":119,"contacts":26},"Birmingham Heartlands Hospital","Birmingham","United Kingdom","UK",{"type":38,"coordinates":116},[117,118],-1.89983,52.48142,{"lat":118,"lon":117},{"facility":121,"status":26,"city":122,"state":26,"zip":26,"country":113,"countryCode":114,"cosmosGeoPoint":123,"geoPoint":127,"contacts":26},"University Hospital Bristol","Bristol",{"type":38,"coordinates":124},[125,126],-2.59665,51.45523,{"lat":126,"lon":125},{"facility":129,"status":26,"city":130,"state":26,"zip":26,"country":113,"countryCode":114,"cosmosGeoPoint":131,"geoPoint":135,"contacts":26},"Evelina Children's Hospital","London",{"type":38,"coordinates":132},[133,134],-0.12574,51.50853,{"lat":134,"lon":133},{"facility":137,"status":26,"city":130,"state":26,"zip":26,"country":113,"countryCode":114,"cosmosGeoPoint":138,"geoPoint":140,"contacts":26},"Great Ormond Street Hospital",{"type":38,"coordinates":139},[133,134],{"lat":134,"lon":133},{"facility":142,"status":26,"city":130,"state":26,"zip":26,"country":113,"countryCode":114,"cosmosGeoPoint":143,"geoPoint":145,"contacts":26},"King's College Hospital",{"type":38,"coordinates":144},[133,134],{"lat":134,"lon":133},{"facility":147,"status":26,"city":130,"state":26,"zip":26,"country":113,"countryCode":114,"cosmosGeoPoint":148,"geoPoint":150,"contacts":26},"St. Mary's Hospital",{"type":38,"coordinates":149},[133,134],{"lat":134,"lon":133},{"facility":152,"status":26,"city":153,"state":26,"zip":26,"country":113,"countryCode":114,"cosmosGeoPoint":154,"geoPoint":158,"contacts":26},"Nottingham City Hospital Campus","Nottingham",{"type":38,"coordinates":155},[156,157],-1.15047,52.9536,{"lat":157,"lon":156},{"facility":160,"status":26,"city":161,"state":26,"zip":26,"country":113,"countryCode":114,"cosmosGeoPoint":162,"geoPoint":166,"contacts":26},"John Radcliffe Hospital","Oxford",{"type":38,"coordinates":163},[164,165],-1.25596,51.75222,{"lat":165,"lon":164},{"type":168,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[170,173],{"name":171,"class":172},"Medical Research Council","OTHER_GOV",{"name":174,"class":172},"ANRS, Emerging Infectious Diseases","100147864","phase-2-koncert-a-kaletra-once-daily-randomised-trial-of-the-pharmacokinetics-safety-and-efficacy-of-twice-daily-versus-once-daily-lopinavirritonavir-tablets-dosed-by-weight-as-part-of-combination-antiretroviral-therapy-in-human-immunodeficiency-virus-1-hiv-1-infected-children-penta-18-100147864",false,"NCT01196195","KONCERT A Kaletra ONCE Daily Randomised Trial of the Pharmacokinetics, Safety and Efficacy of Twice-daily Versus Once-daily Lopinavir\u002FRitonavir Tablets Dosed by Weight as Part of Combination Antiretroviral Therapy in Human Immunodeficiency Virus-1 (HIV-1) Infected Children (PENTA 18)","KONCERT","Inclusion Criteria:\n\n* aged \\\u003C18 years (up to 18th birthday) with confirmed HIV-1 infection\n* weight ≥15 kg\n* able to swallow tablets\n* stable (i.e. CD4 not declining) on a combination antiretroviral regimen that has included lopinavir\u002Fritonavir for at least 24 weeks\n* taking lopinavir\u002Fritonavir dosed twice-daily and be willing at the screening visit to change to tablet formulation (if not currently taking tablets) and to change the lopinavir\u002Fritonavir dose to follow the recommended FDA dosing plan based on body weight bands as necessary (see 7.2.2); if participating in the PK study\\*, be willing at the screening visit to change to lopinavir\u002Fritonavir half strength formulation tablets (100\u002F25mg) only, dosed twice-daily and change the lopinavir\u002Fritonavir dose to follow the recommended FDA dosing plan based on body weight bands as necessary (see 7.2.1)\n* viral suppression (HIV-1 RNA \\\u003C50 copies\u002Fml) for at least the prior 24 weeks (minimum of 2 measurements).\n* children and caregivers willing to participate in the PK study if they are among a minimum of the first 16 children enrolled in each body weight band in the trial, including a second PK assessment if randomised to switch to once-daily lopinavir\u002Fritonavir.\n* parents\u002Fcarers and children, where applicable, give informed written consent\n\nExclusion Criteria:\n\n* children on an antiretroviral regimen that includes a non-nucleoside reverse transcriptase inhibitor (NNRTI), fosamprenavir or nelfinavir\n* children who have previously failed virologically on a protease inhibitor (PI) containing regimen (where virological failure is defined as two successive HIV-1 RNA results\\>1000 copies\u002Fml (confirmed) more than 24 weeks after starting highly active antiretroviral therapy (HAART), i.e changes for toxicity are not counted as failure)\n* acute illness\n* abnormal renal or liver function (grade 3 or above)\n* receiving concomitant therapy except for prophylaxis; Some treatments may be allowed, but must first be discussed with a trial medical expert\n* pregnancy or risk of pregnancy in females of child bearing potential","ALL","18 Years",{"count":185,"type":186},173,"ACTUAL","INTERVENTIONAL",[189,190],"PHASE2","PHASE3","The trial will evaluate the pharmacokinetics, safety, efficacy and acceptability of twice- and once-daily dosing of lopinavir\u002Fritonavir tablets (Kaletra) dosed by weight in HIV-1 infected children who are currently taking lopinavir\u002Fritonavir as part of their combination antiretroviral therapy and who are currently achieving virological suppression (\\\u003C50 copies\u002Fml). Specifically:\n\n* To confirm weight-based dosing recommendations by evaluating the pharmacokinetics of twice-daily lopinavir\u002Fritonavir half strength formulation tablets dosed on body weight and comparing to historical adult and paediatric data of pharmacokinetics of lopinavir\u002Fritonavir soft gel capsules and oral solution respectively (1, 2).\n* To compare the pharmacokinetics of twice-daily lopinavir\u002Fritonavir tablets with once-daily dosing in the same children.\n* To evaluate whether once-daily dosing of lopinavir\u002Fritonavir is comparable to twice-daily dosing in terms of virological suppression at 48 weeks. Adherence and acceptability will also be compared.",[193],"Antiretroviral Therapy in HIV-1 Infected Children",[195,196,197],"antiretroviral therapy","child","HIV-1","COMPLETED","2013-10-25",{"date":201,"type":202},"2013-10-28","ESTIMATED",{"date":204,"type":26},"2010-08",{"date":206,"type":186},"2013-08",{"name":5,"class":6},17]