Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2026-01-21 @ 11:01 PM
Study NCT ID:
NCT01450618
Status:
COMPLETED
Last Update Posted:
2012-12-05
First Post:
2011-09-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Tolerability of Protease Inhibitors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-04', 'studyFirstSubmitDate': '2011-09-21', 'studyFirstSubmitQcDate': '2011-10-11', 'lastUpdatePostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of patients.with new onset GI symptoms after initiating an ATV, DRV, FPV, or LPV containing combination antiretroviral therapy (cART) regimen', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Percent of patients with new onset lipid abnormalities or new onset jaundice (separately) after initiating an ATV, DRV, FPV, or LPV containing combination antiretroviral therapy (cART) regimen', 'timeFrame': '6 months'}, {'measure': 'Healthcare utilization', 'timeFrame': '6 months'}, {'measure': 'Healthcare costs', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['HIV']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/home.aspx', 'label': 'BMS Clinical Trials Disclosure'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}, {'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'For FDA Safety Alerts and Recalls refer to the following link:'}]}, 'descriptionModule': {'briefSummary': 'This study will be a retrospective observational study assessing identifiable tolerability problems in terms of their comparative incidence among Human Immunodeficiency Virus (HIV) patients treated with cART regimens including one of four different protease inhibitors \\[Atazanavir sulfate (ATV), Darunavir (DRV), Fosamprenavir (FPV), or Lopinavir (LPV)\\] and the impact of these identifiable tolerability problems on PI persistence, healthcare utilization, and healthcare costs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Employees and dependents with employer-based health insurance coverage', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Initiated treatment with a Protease inhibitor (PI)-based Combination antiretroviral therapy (cART) regimen\n* Between 18-64 years of age on the index date\n* At least 6 months of continuous enrollment and pharmacy benefits prior to the index date\n* At least 6 months of continuous enrollment and pharmacy benefits following the index date\n* At least 1 medical claim during the 6-month follow-up period'}, 'identificationModule': {'nctId': 'NCT01450618', 'briefTitle': 'Comparative Tolerability of Protease Inhibitors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Comparative Tolerability of Protease Inhibitors and the Associated Impact on Persistence, Healthcare Utilization, and Healthcare Costs', 'orgStudyIdInfo': {'id': 'AI424-435'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Atazanavir', 'description': 'HIV patients on antiretroviral therapy using Atazanavir'}, {'label': 'Darunavir', 'description': 'HIV patients on antiretroviral therapy using Darunavir'}, {'label': 'Fosamprenavir', 'description': 'HIV patients on antiretroviral therapy using Fosamprenavir'}, {'label': 'Lopinavir', 'description': 'HIV patients on antiretroviral therapy using Lopinavir'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}