Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2026-01-05 @ 6:57 AM
Study NCT ID:
NCT01015092
Status:
COMPLETED
Last Update Posted:
2009-11-17
First Post:
2009-11-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Risk Evaluation and Antiretrovirals in HIV
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': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1024}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-16', 'studyFirstSubmitDate': '2009-11-16', 'studyFirstSubmitQcDate': '2009-11-16', 'lastUpdatePostDateStruct': {'date': '2009-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '10 year predicted cardiovascular risk', 'timeFrame': 'AT time of clinic attendence'}], 'secondaryOutcomes': [{'measure': 'coronary heart disease risk', 'timeFrame': 'at time of clinic attendence'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'Cardiovascular', 'Coronary hear disease', 'HAART', 'antiretroviral'], 'conditions': ['Cardiovascular Risk', 'HIV Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the main factors contributing to predicted 10 year cardiovascular risk in an HIV infected cohort, and the role of anti-HIV drug use in altering this risk'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All HIV outpatients patients attending two London Hospitals', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Serologically proven HIV infection\n* Attending general HIV outpatient clinic\n\nExclusion Criteria:\n\n* Attending a specialist outpatient clinic which might lead to recruitment bias'}, 'identificationModule': {'nctId': 'NCT01015092', 'acronym': 'CREATE1', 'briefTitle': 'Cardiovascular Risk Evaluation and Antiretrovirals in HIV', 'organization': {'class': 'OTHER', 'fullName': "King's College London"}, 'officialTitle': 'Predicted 10-year Coronary Heart Disease Risk in HIV and Implications for Clinical Management: the CREATE Study', 'orgStudyIdInfo': {'id': '05/Q0702/156'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'unselected HIV outpatient attendees', 'description': 'All HIV patients attending for general HIV care at 2 London Hospitals'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE30AA', 'city': 'London', 'country': 'United Kingdom', 'facility': "Guys & ST Thomas' Foundation Hospitals", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Barry S Peters, MB BS. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "King's College London"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College London", 'class': 'OTHER'}, 'collaborators': [{'name': "Guy's and St Thomas' NHS Foundation Trust", 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr Barry Stephen Peters', 'oldOrganization': 'Kings College London'}}}}