Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-02-03 @ 5:33 PM
Study NCT ID:
NCT02426866
Status:
COMPLETED
Last Update Posted:
2015-04-27
First Post:
2015-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk of CV Events With EFV vs. EFV-free Regimens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'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': 'D012897', 'term': 'Slow 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': 'C098320', 'term': 'efavirenz'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29612}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-22', 'studyFirstSubmitDate': '2015-04-22', 'studyFirstSubmitQcDate': '2015-04-22', 'lastUpdatePostDateStruct': {'date': '2015-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular events specifically based on incidence rate and compare the hazard between the HIV infected patient initiating efavirenz-containing antiretroviral regimen and efavirenz-free antiretroviral regimen', 'timeFrame': 'upto 1 to 5 years', 'description': 'cardiovascular events specifically based on incidence rate and compare the hazard (myocardial infarction, stroke,percutaneous coronary intervention, coronary artery bypass graft, and composite of aforementioned events) between the HIV infected patient initiating efavirenz-containing antiretroviral regimen and efavirenz-free antiretroviral regimen'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['HIV/AIDS']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/Pages/home.aspx', 'label': 'Related Info'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether there is an increased risk of cardiovascular events (CV) with regimens containing efavirenz (EFV) versus other regimens in patients with HIV.'}, 'eligibilityModule': {'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Commercial insurance database and Medicaid database', 'healthyVolunteers': False, 'eligibilityCriteria': 'For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Aged 18 years or older on the index date\n* Have at least one pharmacy claim for efavirenz or a drug in the comparison cohort during the period spanning January 1, 2007 through December 31,2013.\n* Clinical Modification (ICD-9) diagnosis code for HIV infection including 042 (HIV disease), V08 (asymptomatic HIV infection status), 795.71 (nonspecific serologic evidence of HIV), and 079.53 (HIV, type 2) any time prior to the index claim.\n* Have at least 6 months (180 days) of continuous enrollment prior to the index claim\n\nExclusion Criteria:\n\n* Patients who have been dispensed any antiretroviral medications anytime before the index date including the 180-day baseline period\n* Patients with evidence of a cardiovascular outcome of interest during the 180-day baseline period'}, 'identificationModule': {'nctId': 'NCT02426866', 'briefTitle': 'Risk of CV Events With EFV vs. EFV-free Regimens', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'The Risk of Cardiovascular Events Among HIV Patients Initiating Efavirenz-containing Versus Efavirenz-free Antiretroviral Regimens', 'orgStudyIdInfo': {'id': 'AI266-414'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient with Efavirenz exposure', 'description': 'Patient with Efavirenz exposure', 'interventionNames': ['Drug: Efavirenz']}, {'label': 'Patient without Efavirenz exposure', 'description': 'Patient without Efavirenz exposure', 'interventionNames': ['Drug: Efavirenz']}], 'interventions': [{'name': 'Efavirenz', 'type': 'DRUG', 'armGroupLabels': ['Patient with Efavirenz exposure', 'Patient without Efavirenz exposure']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Truven health', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}