Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT00168220
Status:
WITHDRAWN
Last Update Posted:
2012-01-20
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predictors of Drug Hypersensitivity in HIV Infected Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], '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': 'plasma, DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Insufficient recruitment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'lastUpdateSubmitDate': '2012-01-19', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2012-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Treatment Experienced', 'HIV'], 'conditions': ['HIV Infections', 'Hypersensitivity']}, 'descriptionModule': {'briefSummary': 'A case-control study to look at hypersensitive and tolerant individuals matched for HLA genetic predisposition, when considering predictors of drug hypersensitivity.The study aims to identify the immunological factors increasing the risk of drug reactions in HIV positive individuals.', 'detailedDescription': '1. To determine in a case control study clinical parameters associated with drug HSR to abacavir, nevirapine and efavirenz in HIV infected subjects.\n2. To measure functional and numerical differences in DC populations and responses to TLR ligands in patients with HSR and tolerant subjects sharing genetic markers for susceptibility to HSR.\n3. Identify the role of different DC populations in the development of abacavir reaction by mixing and depletion studies in sensitized subjects and in in vitro assays for abacavir hypersensitivity.\n4. To measure T cell parameters including T cell viability in culture, and expression of fas and fasL on blood mononuclear cells in HIV infected controls and HSR patients.\n5. To measure blood T cell populations including drug reactive T cells and T regulatory cells in tolerant and reactive subjects with genetic susceptibility to Abacavir and Nevirapine HSR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HIV infection, exposed to antiretroviral treatment, either tolerant or hypersensitive to treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV infected patients on treatment with the drugs Efavirenz, Nevirapine, or Abacavir.\n* Age over 18 Cases are those who have had a hypersensitivity reaction, and controls are those who have had no reaction'}, 'identificationModule': {'nctId': 'NCT00168220', 'briefTitle': 'Predictors of Drug Hypersensitivity in HIV Infected Subjects', 'organization': {'class': 'OTHER', 'fullName': 'The Alfred'}, 'officialTitle': 'Predictors of Drug Hypersensitivity in HIV Infected Subjects', 'orgStudyIdInfo': {'id': '113/05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Drug hypersensitive group', 'description': 'HIV positive patients with a history of a Hypersensitivity Reaction to the antiretroviral medications Nevirapine, Abacavir or Efavirenz'}, {'label': 'Drug tolerant group', 'description': 'HIV positive patients selected based on drug exposure greater than 2 weeks and tolerance to to Abacavir or Nevirapine.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Paul Cameron, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Alfred'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Alfred', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Health and Medical Research Council, Australia', 'class': 'OTHER'}, {'name': 'Monash University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Jennifer Hoy', 'investigatorFullName': 'Jennifer Hoy', 'investigatorAffiliation': 'The Alfred'}}}}