Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-01-10 @ 3:36 PM
Study NCT ID:
NCT00476502
Status:
COMPLETED
Last Update Posted:
2012-04-05
First Post:
2007-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Genetic Polymorphisms in Thai HIV-1 Infected Patients on SQV/r
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'PBMC'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-03', 'studyFirstSubmitDate': '2007-05-20', 'studyFirstSubmitQcDate': '2007-05-21', 'lastUpdatePostDateStruct': {'date': '2012-04-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['genetic polymorphism', 'CYP 3A', 'MDR-1', 'Thai', 'HIV', 'Treatment Experienced'], 'conditions': ['HIV Infections']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.hivnat.org', 'label': 'The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)'}]}, 'descriptionModule': {'briefSummary': 'Study of genetic polymorphisms of CYP #A and MDR-1 genes in Thai HIV-1 infected patients on saquinavir/ritonavir.', 'detailedDescription': 'Genetic polymorphisms will be investigated by polymerase-chain reaction (PCR) and drug levels of saquinavir will be determined by high phase liquid chromatography with UV-detected (HPLC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients on stable SQV based HAART therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-infected persons who have been enrolled in the Staccato study\n* On low-dose ritonavir boosted saquinavir at the time blood samples are collected\n\nExclusion Criteria:\n\n* Inability to understand the nature and extent of the study and the procedures required'}, 'identificationModule': {'nctId': 'NCT00476502', 'briefTitle': 'Study of Genetic Polymorphisms in Thai HIV-1 Infected Patients on SQV/r', 'organization': {'class': 'OTHER', 'fullName': 'The HIV Netherlands Australia Thailand Research Collaboration'}, 'officialTitle': 'Study of Genetic Polymorphisms of CYP 3A and MDR-1 Genes in Thai HIV-1 Infected Patients on Saquinavir/Ritonavir', 'orgStudyIdInfo': {'id': 'HIV-NAT 031'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'patients involved in structured interruption therapy', 'interventionNames': ['Genetic: identify genetic polymorphism in Thai HIV infected']}], 'interventions': [{'name': 'identify genetic polymorphism in Thai HIV infected', 'type': 'GENETIC', 'description': 'Gene sequencing of Cyp450 metabolic pathway', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'The HIV Netherlands Australia Thailand Research Collaboration (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 (HIV-NAT)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The HIV Netherlands Australia Thailand Research Collaboration', 'class': 'OTHER'}, 'collaborators': [{'name': 'Roche Pharma AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}