Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2026-02-21 @ 9:22 AM
Study NCT ID:
NCT00168233
Status:
COMPLETED
Last Update Posted:
2012-01-20
First Post:
2005-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of HIV and Its Treatment on Reverse Cholesterol Transport
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-19', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2012-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Treatment Naive', 'HIV'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'To investigate the effect of treatment of HIV infection with highly active antiretroviral therapy on individual steps of reverse cholesterol transport, endothelial function and intima-media thickness in HIV patients.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HIV infected patients naive to ARV therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male patients with HIV infection (3 groups of 50 patients each)\n* HIV infected patients, naïve to ARV therapy and not likely to need to commence therapy for the duration of follow-up (12 months)\n* HIV-infected patients, PI naïve, initiating therapy with PI-containing HAART (ARV naïve or NNRTI experienced changing to PI regimen)\n* HIV-infected patients naïve to ARV therapy, initiating NNRTI-containing regimen\n\nExclusion criteria\n\n* Treatment with any form of lipid lowering drugs, including fish oils.\n* Body Mass Index greater than 27.'}, 'identificationModule': {'nctId': 'NCT00168233', 'briefTitle': 'Impact of HIV and Its Treatment on Reverse Cholesterol Transport', 'organization': {'class': 'OTHER', 'fullName': 'The Alfred'}, 'officialTitle': 'Impact of HIV Infection and Treatment With Highly Active Antiretroviral Therapy on Reverse Cholesterol Transport', 'orgStudyIdInfo': {'id': '54/05'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'No antiretroviral therapy for 12 months'}, {'label': '2', 'description': 'Initiating ARV therapy with an NNRTI based regimen'}, {'label': '3', 'description': 'Initiating ARV therapy with a PI based regimen'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Alfred Hospital and Baker Heart Research Institute', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Dmitri Sviridov, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Baker Heart Research Institute, Commercial Road, Melbourne'}, {'name': 'Jennifer Hoy, A/Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alfred Hospital, Melbourne, Vic 3004'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Alfred', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Health and Medical Research Council, Australia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Jennifer Hoy', 'investigatorFullName': 'Jennifer Hoy', 'investigatorAffiliation': 'The Alfred'}}}}