Ignite Creation Date:
2025-12-26 @ 5:17 PM
Ignite Modification Date:
2026-02-27 @ 4:31 PM
Study NCT ID:
NCT00476606
Status:
COMPLETED
Last Update Posted:
2025-03-17
First Post:
2007-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Cohort of Children With HIV Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015215', 'term': 'Zidovudine'}, {'id': 'D018119', 'term': 'Stavudine'}, {'id': 'D016049', 'term': 'Didanosine'}, {'id': 'D019259', 'term': 'Lamivudine'}, {'id': 'D019829', 'term': 'Nevirapine'}, {'id': 'C098320', 'term': 'efavirenz'}, {'id': 'D019258', 'term': 'Saquinavir'}, {'id': 'D019469', 'term': 'Indinavir'}, {'id': 'D019438', 'term': 'Ritonavir'}, {'id': 'D019888', 'term': 'Nelfinavir'}], 'ancestors': [{'id': 'D013936', 'term': 'Thymidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D007288', 'term': 'Inosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D016047', 'term': 'Zalcitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'PBMC'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-14', 'studyFirstSubmitDate': '2007-05-20', 'studyFirstSubmitQcDate': '2007-05-21', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. To collect clinical and immunologic data of children treated with HAART 2. To collect clinical outcome data on children with HIV infection 3. To provide the best possible care to children with HIV infection', 'timeFrame': 'every 3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV children', 'HAART', 'ARV', 'Second line HAART', 'Viral Load', 'Combination drug', 'Treatment Experienced', 'Treatment Naive'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Bunupuradah T., Puthanakit T., Boonrak P., Butterworth O., Mengthaisong T., Intasan J., Ubolyam S., Kosalaraksa P., Engchanil C., Pancharoen C., Lumbiganond P., Phanuphak P., Ananworanich J., HIV-NAT Pediatric Study Team. Efficacy and safety of non nucleoside reverse transcriptase inhibitor (NNRTI) based highly active antiretroviral therapy (HAART) in Thai children with HIV, poster No. TUPEB128. Poster presented at the 4th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention, Sydney, Australia, July 22-25, 2007'}, {'pmid': '22026962', 'type': 'RESULT', 'citation': 'Bunupuradah T, Puthanakit T, Kosalaraksa P, Kerr S, Boonrak P, Prasitsuebsai W, Lumbiganon P, Mengthaisong T, Phasomsap C, Pancharoen C, Ruxrungtham K, Ananworanich J. Immunologic and virologic failure after first-line NNRTI-based antiretroviral therapy in Thai HIV-infected children. AIDS Res Ther. 2011 Oct 26;8:40. doi: 10.1186/1742-6405-8-40.'}, {'pmid': '24625136', 'type': 'RESULT', 'citation': 'Sirikum C, Sophonphan J, Chuanjaroen T, Lakonphon S, Srimuan A, Chusut P, Do TC, Prasitsuebsai W, Puthanakit T, Ananworanich J, Bunupuradah T; HIV-NAT 015 study team. HIV disclosure and its effect on treatment outcomes in perinatal HIV-infected Thai children. AIDS Care. 2014;26(9):1144-9. doi: 10.1080/09540121.2014.894614. Epub 2014 Mar 13.'}], 'seeAlsoLinks': [{'url': 'http://www.hivnat.org', 'label': 'Click here for more information about HIV-NAT 015'}]}, 'descriptionModule': {'briefSummary': 'To evaluate clinical and immunological outcome of children treated with HAART.', 'detailedDescription': 'This is a long term cohort study that was started in 2002. Currently, there are 120 children enrolled in the study and are receiving HIV care according to standard practice set by the Thai Ministry of Public Health. HIV-infected parents also receive care at the same clinic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HIV-infected infants, children and adolescents (range age 1 day - 20 years old) who have participated in HIV-NAT trials', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children who are part of the ATC program at Chulalongkorn hospital and at HIV-NAT, The Thai Red Cross AIDS research center\n* Children who fulfil criteria to start HAART according to the ATC program\n* Children who are switched to second regimen or salvage therapy\n* Children who are on any antiretroviral regimens, including post trial children from other HIV-NAT study (both at HIV-NAT and Khon Kaen University sites)\n* Children with HIV infection who are not on antiretroviral therapy\n* Caretakers understand the purpose of data and plasma samples collection, and have signed the consent form\n\nExclusion Criteria:\n\n* Patients and caretakers may choose to stop HAART at anytime during the study. If they agree, we would continue to follow them in this study.'}, 'identificationModule': {'nctId': 'NCT00476606', 'briefTitle': 'A Prospective Cohort of Children With HIV Infection', 'organization': {'class': 'OTHER', 'fullName': 'The HIV Netherlands Australia Thailand Research Collaboration'}, 'officialTitle': 'Treatment Outcome of Children With HIV Infection', 'orgStudyIdInfo': {'id': 'HIV-NAT 015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Long-term pediatric cohort', 'description': 'Long-term follow-up cohort since 2003', 'interventionNames': ['Drug: Zidovudine, Stavudine, Didanosine, Lamivudine', 'Drug: Nevirapine, Efavirenz', 'Drug: LPV/r, Saquinavir, Indinavir, Ritonavir, Nelfinavir']}], 'interventions': [{'name': 'Zidovudine, Stavudine, Didanosine, Lamivudine', 'type': 'DRUG', 'description': 'Refer to the Thai guideline for HIV management 2007', 'armGroupLabels': ['Long-term pediatric cohort']}, {'name': 'Nevirapine, Efavirenz', 'type': 'DRUG', 'description': 'Refer to the Thai guideline for HIV management 2007', 'armGroupLabels': ['Long-term pediatric cohort']}, {'name': 'LPV/r, Saquinavir, Indinavir, Ritonavir, Nelfinavir', 'type': 'DRUG', 'description': 'Refer to the Thai guideline for HIV management 2007', 'armGroupLabels': ['Long-term pediatric cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'HIV-NAT', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10330', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Pediatric infectious diseases section, Chulalongkorn University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '40002', 'city': 'Khon Kaen', 'country': 'Thailand', 'facility': 'Khon Kaen University', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}], 'overallOfficials': [{'name': 'Kiat Ruxrungtham, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HIV-NAT, The Thai Red Cross AIDS Research Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The HIV Netherlands Australia Thailand Research Collaboration', 'class': 'OTHER'}, 'collaborators': [{'name': 'Khon Kaen University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}