Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT01139905
Status:
COMPLETED
Last Update Posted:
2015-03-26
First Post:
2010-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lopinavir/Ritonavir (LPV/r) Tablet in HIV Infected Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D061466', 'term': 'Lopinavir'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-24', 'studyFirstSubmitDate': '2010-06-04', 'studyFirstSubmitQcDate': '2010-06-08', 'lastUpdatePostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assess the level of lopinavir trough level >1 mg/L in low dose lopinavir (reduction by 70%)', 'timeFrame': '4 months', 'description': 'study drug Aluvia (lopinavir/ritonavir 100/25 mg)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lopinavir/ritonavir', 'pharmacokinetic', 'low dose', 'HIV-infected children', 'pharmacokinetics of low-dose lopinavir/ritonavir in HIV-1 infected Thai children.'], 'conditions': ['HIV-1 Infections']}, 'referencesModule': {'references': [{'pmid': '22293065', 'type': 'RESULT', 'citation': 'Klinklom A, Puthanakit T, Gorowara M, Phasomsap C, Kerr S, Sriheara C, Ananworanich J, Burger D, Ruxrungtham K, Pancharoen C. Low dose lopinavir/ritonavir tablet achieves adequate pharmacokinetic parameters in HIV-infected Thai adolescents. Antivir Ther. 2012;17(2):283-9. doi: 10.3851/IMP1958. Epub 2011 Nov 10.'}], 'seeAlsoLinks': [{'url': 'http://www.hivnat.org', 'label': 'HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)'}]}, 'descriptionModule': {'briefSummary': 'To study the pharmacokinetics of low-dose lopinavir/ritonavir tablet in HIV-1 infected Thai children.', 'detailedDescription': 'This is an open-label, single arm study to compare standard dose with a new tablet formulation of a lower dose of lopinavir/ritonavir in HIV-1 infected children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. HIV infection\n2. Age \\< 18 years old\n3. BW \\> 25 kg\n4. HIV RNA viral load \\< 50 copies within 6 months\n5. Written informed consent\n\nExclusion Criteria:\n\n1. Active opportunistic infection\n2. Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.\n3. Use of concomitant medications that may interfere with the pharmacokinetics of lopinavir/ritonavir'}, 'identificationModule': {'nctId': 'NCT01139905', 'briefTitle': 'Lopinavir/Ritonavir (LPV/r) Tablet in HIV Infected Children', 'organization': {'class': 'OTHER', 'fullName': 'The HIV Netherlands Australia Thailand Research Collaboration'}, 'officialTitle': 'Pharmacokinetics of Low- Dose Lopinavir/Ritonavir Tablet Formulation HIV-1 Infected Children', 'orgStudyIdInfo': {'id': 'HIV-NAT 100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'standard dose of lopinavir/ritonavir 100/25 mg tablet q 12 hour', 'interventionNames': ['Other: lopinavir/ritonavir']}], 'interventions': [{'name': 'lopinavir/ritonavir', 'type': 'OTHER', 'description': 'standard dose of lopinavir/ritonavir 100/25 mg tablet q 12 hour.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'HIV-NAT', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Kiat Ruxrungtham, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The HIV Netherlands Australia Thailand Research Collaboration'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The HIV Netherlands Australia Thailand Research Collaboration', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chulalongkorn University', 'class': 'OTHER'}, {'name': 'Radboud University Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}