Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-30 @ 6:07 PM
Study NCT ID:
NCT01225406
Status:
COMPLETED
Last Update Posted:
2020-07-17
First Post:
2010-10-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Third Line Highly Active Antiretroviral Therapy (HAART) in HIV-infected Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068698', 'term': 'Tenofovir'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma and PBMC'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-15', 'studyFirstSubmitDate': '2010-10-18', 'studyFirstSubmitQcDate': '2010-10-19', 'lastUpdatePostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'undetectable viral load', 'timeFrame': '48 weeks', 'description': 'Primary endpoint will be the proportions of subjects with HIV RNA below 400 and 50 copies/ml at 48 weeks.'}], 'secondaryOutcomes': [{'measure': 'Hyperlipidemia', 'timeFrame': '48 weeks', 'description': 'Number of subjects with hyperlipidemia as a measure of safety'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Third line ARV therapy', 'HIV RNA', 'Absolute CD4+ T cell count', 'serious adverse events (SAEs)', 'Drug resistance'], 'conditions': ['This Study is Designed to Collect Treatment Data of Thai Children on Third Line ARV Therapy']}, 'referencesModule': {'references': [{'pmid': '22954687', 'type': 'RESULT', 'citation': 'Chokephaibulkit K, Prasitsuebsai W, Wittawatmongkol O, Gorowara M, Phongsamart W, Sophonphan J, Kerr SJ, Vanprapar N, Puthanakit T, Pasomsap C, Suwanlerk T, Sekar V, Burger D, Ananworanich J; HIV-NAT 113 Pharmacokinetic Study Group. Pharmacokinetics of darunavir/ritonavir in Asian HIV-1-infected children aged >/=7 years. Antivir Ther. 2012;17(7):1263-9. doi: 10.3851/IMP2347. Epub 2012 Sep 6.'}], 'seeAlsoLinks': [{'url': 'http://www.hivnat.org', 'label': 'The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)'}]}, 'descriptionModule': {'briefSummary': 'This is an observational cohort study of virologic and immunologic outcome after at least 48 weeks of third line antiretroviral therapy. Upto 150 children at 8 Thai sites will be enrolled. Third line antiretroviral therapy in this study is defined as an antiretroviral (ARV) regimen in a patient who has failure or intolerance to first line NNRTI-based therapy and second line PI-based therapy. Such regimens may contain new drugs or drug classes such as darunavir, tipranavir, etravirine and raltegravir The knowledge gained from this study will help the Thai government in planning its strategy to provide third line ARV therapy to children within the national program.', 'detailedDescription': 'The primary objective of this study is to assess the virological efficacy, as measured by the proportions of children with HIV RNA below 400 and 50 copies/ml at 48 weeks after initiating third line ARV therapy.\n\nThird line ARV therapy is defined as an ARV regimen in a patient who has failure or intolerance to first line NNRTI-based therapy and second line PI-based therapy. Such regimens may contain new drugs or drug classes such as darunavir, tipranavir, etravirine and raltegravir'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Thai children aged \\< 18 years old who are on or are switching to third line antiretroviral therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChildren (\\< 18 years old) with HIV infection may enroll if one of the following criteria is met:\n\n1. Have resistance to at least one drug in each of the 3 classes (NRTI, NNRTI and PI) and have plasma HIV RNA \\> 1000 copies/ml prior to switching to third line ARV therapy\n2. Have intolerance to the current NRTI, NNRTI or PI treatment and need to receive darunavir, etravirine, tipranavir or raltegravir\n\nExclusion Criteria:\n\n1. Have hepatic impairment with ALT ≥ 5 upper limit of normal\n2. Pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT01225406', 'briefTitle': 'Third Line Highly Active Antiretroviral Therapy (HAART) in HIV-infected Children', 'organization': {'class': 'OTHER', 'fullName': 'The HIV Netherlands Australia Thailand Research Collaboration'}, 'officialTitle': 'Treatment Cohort of HIV-infected Children With Resistance or Intolerance to Non Nucleoside Reverse Transcriptase Inhibitor (NNRTI) First Line and PI Second Line Antiretroviral Therapy', 'orgStudyIdInfo': {'id': 'HIV-NAT 113'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'third line naive', 'description': 'Children on second line or other regimen who switch or start third line regimen', 'interventionNames': ['Drug: Tenofovir']}, {'label': 'third line experienced', 'description': 'children who are on third line regimen', 'interventionNames': ['Drug: Tenofovir']}], 'interventions': [{'name': 'Tenofovir', 'type': 'DRUG', 'armGroupLabels': ['third line experienced', 'third line naive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22000', 'city': 'Chanthaburi', 'state': 'Changwat Chanthaburi', 'country': 'Thailand', 'facility': 'Prapokklao Chantaburi', 'geoPoint': {'lat': 12.60961, 'lon': 102.10447}}, {'zip': '10330', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Chulalongkorn University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10330', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'HIV-NAT', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Siriraj Hospital, Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '50180', 'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Nakornping Hospital', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}, {'zip': '57000', 'city': 'Chiang Rai', 'country': 'Thailand', 'facility': 'Chiang Rai Regional Hospital', 'geoPoint': {'lat': 19.90858, 'lon': 99.8325}}, {'zip': '40002', 'city': 'Khon Kaen', 'country': 'Thailand', 'facility': 'Khon Kaen University', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}, {'zip': '11000', 'city': 'Nonthaburi', 'country': 'Thailand', 'facility': 'Bamrasnaradura Institute', 'geoPoint': {'lat': 13.86075, 'lon': 100.51477}}, {'zip': '32000', 'city': 'Surin', 'country': 'Thailand', 'facility': 'Surin Hospital', 'geoPoint': {'lat': 14.88181, 'lon': 103.49364}}], 'overallOfficials': [{'name': 'Thanyawee Puthanakit, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chulalongkorn University Bangkok'}, {'name': 'Kulkanya Chokephaibulkit, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Siriraj Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The HIV Netherlands Australia Thailand Research Collaboration', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Education, Thailand', 'class': 'OTHER'}, {'name': 'National Health Security Office, Thailand', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}