Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2026-04-09 @ 11:32 AM
Study NCT ID:
NCT01196195
Status:
COMPLETED
Last Update Posted:
2013-10-28
First Post:
2010-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
KONCERT A Kaletra ONCE Daily Randomised Trial of the Pharmacokinetics, Safety and Efficacy of Twice-daily Versus Once-daily Lopinavir/Ritonavir Tablets Dosed by Weight as Part of Combination Antiretroviral Therapy in Human Immunodeficiency Virus-1 (HIV-1) Infected Children (PENTA 18)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-05-13', 'releaseDate': '2015-04-28'}, {'resetDate': '2024-08-22', 'releaseDate': '2024-04-03'}], 'estimatedResultsFirstSubmitDate': '2015-04-28'}}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-25', 'studyFirstSubmitDate': '2010-08-16', 'studyFirstSubmitQcDate': '2010-09-07', 'lastUpdatePostDateStruct': {'date': '2013-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to twice-daily dosing in terms of virological suppression. This is measured by HIV-1 RNA ≥50 copies/ml (confirmed).', 'timeFrame': 'week 48', 'description': 'To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to twice-daily dosing in terms of virological suppression. This is measured by HIV-1 Ribonucleic acid (RNA) ≥50 copies/ml (confirmed).'}, {'measure': 'To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to twice-daily dosing in terms of virological suppression. This is measured by HIV-1 RNA ≥50 copies/ml (confirmed).', 'timeFrame': 'Week 36', 'description': 'To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to twice-daily dosing in terms of virological suppression. This is measured by HIV-1 RNA ≥50 copies/ml (confirmed).'}, {'measure': 'To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to twice-daily dosing in terms of virological suppression. This is measured by HIV-1 RNA ≥50 copies/ml (confirmed).', 'timeFrame': 'week 24', 'description': 'To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to twice-daily dosing in terms of virological suppression. This is measured by HIV-1 RNA ≥50 copies/ml (confirmed).'}, {'measure': 'To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to twice-daily dosing in terms of virological suppression. This is measured by HIV-1 RNA ≥50 copies/ml (confirmed).', 'timeFrame': 'week 12', 'description': 'To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to twice-daily dosing in terms of virological suppression. This is measured by HIV-1 RNA ≥50 copies/ml (confirmed).'}, {'measure': 'To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to twice-daily dosing in terms of virological suppression. This is measured by HIV-1 RNA ≥50 copies/ml (confirmed).', 'timeFrame': 'week 8', 'description': 'To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to twice-daily dosing in terms of virological suppression. This is measured by HIV-1 RNA ≥50 copies/ml (confirmed).'}, {'measure': 'To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to twice-daily dosing in terms of virological suppression. This is measured by HIV-1 RNA ≥50 copies/ml (confirmed).', 'timeFrame': 'week 4', 'description': 'To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to twice-daily dosing in terms of virological suppression. This is measured by HIV-1 RNA ≥50 copies/ml (confirmed).'}, {'measure': 'To compare the pharmacokinetics of twice-daily lopinavir/ritonavir tablets with once-daily dosing in the same children', 'timeFrame': 'week 4', 'description': 'Area under the curve (AUC), minimum observed plasma concentration (Cmin) and maximum observed plasma concentration (Cmax) values of lopinavir after once-daily and twice-daily dosing (in the same children)'}], 'secondaryOutcomes': [{'measure': 'To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to twice-daily dosing in terms of virological suppression. This is measured by HIV-1 RNA <400/<50 copies/ml.', 'timeFrame': 'week 24', 'description': 'To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to twice-daily dosing in terms of virological suppression. This is measured by HIV-1 RNA \\<400/\\<50 copies/ml.'}, {'measure': 'To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to twice-daily dosing in terms of virological suppression. This is measured by HIV-1 RNA <400/<50 copies/ml.', 'timeFrame': 'week 48', 'description': 'To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to twice-daily dosing in terms of virological suppression. This is measured by HIV-1 RNA \\<400/\\<50 copies/ml.'}, {'measure': 'Acceptability and adherence to once-daily versus twice-daily dosing of lopinavir/ritonavir tablets', 'timeFrame': 'week 48', 'description': 'Acceptability and adherence to once-daily versus twice-daily dosing of lopinavir/ritonavir tablets, assessed by patient/carer completed questionnaires'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['antiretroviral therapy', 'child', 'HIV-1'], 'conditions': ['Antiretroviral Therapy in HIV-1 Infected Children']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.pentatrials.org/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The trial will evaluate the pharmacokinetics, safety, efficacy and acceptability of twice- and once-daily dosing of lopinavir/ritonavir tablets (Kaletra) dosed by weight in HIV-1 infected children who are currently taking lopinavir/ritonavir as part of their combination antiretroviral therapy and who are currently achieving virological suppression (\\<50 copies/ml). Specifically:\n\n* To confirm weight-based dosing recommendations by evaluating the pharmacokinetics of twice-daily lopinavir/ritonavir half strength formulation tablets dosed on body weight and comparing to historical adult and paediatric data of pharmacokinetics of lopinavir/ritonavir soft gel capsules and oral solution respectively (1, 2).\n* To compare the pharmacokinetics of twice-daily lopinavir/ritonavir tablets with once-daily dosing in the same children.\n* To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to twice-daily dosing in terms of virological suppression at 48 weeks. Adherence and acceptability will also be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged \\<18 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/ritonavir for at least 24 weeks\n* taking lopinavir/ritonavir 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/ritonavir 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/ritonavir half strength formulation tablets (100/25mg) only, dosed twice-daily and change the lopinavir/ritonavir 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 \\<50 copies/ml) 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/ritonavir.\n* parents/carers 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/ml (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'}, 'identificationModule': {'nctId': 'NCT01196195', 'acronym': 'KONCERT', 'briefTitle': 'KONCERT A Kaletra ONCE Daily Randomised Trial of the Pharmacokinetics, Safety and Efficacy of Twice-daily Versus Once-daily Lopinavir/Ritonavir Tablets Dosed by Weight as Part of Combination Antiretroviral Therapy in Human Immunodeficiency Virus-1 (HIV-1) Infected Children (PENTA 18)', 'organization': {'class': 'NETWORK', 'fullName': 'PENTA Foundation'}, 'officialTitle': 'KONCERT A Kaletra ONCE Daily Randomised Trial of the Pharmacokinetics, Safety and Efficacy of Twice-daily Versus Once-daily Lopinavir/Ritonavir Tablets Dosed by Weight as Part of Combination Antiretroviral Therapy in Human Immunodeficiency Virus-1 (HIV-1) Infected Children (PENTA 18)', 'orgStudyIdInfo': {'id': 'KONCERT protocol, version 1.6'}, 'secondaryIdInfos': [{'id': '2009-013648-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QD kaletra', 'description': 'Once daily kaletra', 'interventionNames': ['Drug: Kaletra dosed once daily']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BID kaletra', 'description': 'twice daily dose of kaletra', 'interventionNames': ['Drug: kaletra dosed twice daily']}], 'interventions': [{'name': 'Kaletra dosed once daily', 'type': 'DRUG', 'description': 'Lopinavir/Ritonavir tablets. Dose = 200/50mg or 100/25mg. Frequency = once daily.', 'armGroupLabels': ['QD kaletra']}, {'name': 'kaletra dosed twice daily', 'type': 'DRUG', 'description': 'Lopinavir/Ritonavir tablets. Dose = 200/50mg or 100/25mg. Frequency = twice daily.', 'armGroupLabels': ['BID kaletra']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite University Hospital Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Department of Pediatric Oncology Hematology and Immunology KA02', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'J W Goethe University', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Munich', 'country': 'Germany', 'facility': 'Immundefekt-Ambulanz, Dr. von Haunersches Kinderspital', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': "Our Lady's Children's Hospital", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Emma Childrens Hospital', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'UMC St. Radboud', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '50100', 'city': 'Changklan, Muang', 'state': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Program for HIV Prevention and Treatment (PHPT)/IRD 174'}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'HIV-NAT Thai Red Cross AIDS Research Centre', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Birmingham Heartlands Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'University Hospital Bristol', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "Evelina Children's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Great Ormond Street Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "St. Mary's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham City Hospital Campus', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'John Radcliffe Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PENTA Foundation', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Medical Research Council', 'class': 'OTHER_GOV'}, {'name': 'ANRS, Emerging Infectious Diseases', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-04-28', 'type': 'RELEASE'}, {'date': '2015-05-13', 'type': 'RESET'}, {'date': '2024-04-03', 'type': 'RELEASE'}, {'date': '2024-08-22', 'type': 'RESET'}], 'unpostedResponsibleParty': 'PENTA Foundation'}}}}