Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 3:46 AM
Study NCT ID:
NCT01078233
Status:
COMPLETED
Last Update Posted:
2019-11-25
First Post:
2010-02-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Observational Data Analysis in EuroSIDA (MK-0518-058)
Sponsor:
Organization:
Raw JSON
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Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '0.39'}, {'value': '1.04', 'groupId': 'OG001', 'lowerLimit': '0.73', 'upperLimit': '1.48'}, {'value': '0.64', 'groupId': 'OG002', 'lowerLimit': '0.50', 'upperLimit': '0.81'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)', 'description': 'Lipodystrophy events were defined as the first report for either 1) loss of fat from extremities, buttocks, or face, or 2) accumulation of fat in abdomen, neck, breasts, or other defined location.', 'unitOfMeasure': 'Events per 100 person-years of follow-up', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Person years of follow-up', 'denomUnitsSelected': 'Person years of follow-up', 'populationDescription': 'Intention-to-Treat analysis included follow-up until the end of the follow-up period for the cohort, regardless of whether or not raltegravir or other drugs were discontinued.'}, {'type': 'PRIMARY', 'title': 'Incidence of All-Cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1150', 'groupId': 'OG000'}, {'value': '2608', 'groupId': 'OG001'}, {'value': '3984', 'groupId': 'OG002'}]}, {'units': 'Person years of follow-up', 'counts': [{'value': '2782', 'groupId': 'OG000'}, {'value': '2913', 'groupId': 'OG001'}, {'value': '10149', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir Cohort', 'description': 'Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union) and had at least 1 month prospective follow-up in the Raltegravir Cohort. 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Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.86', 'groupId': 'OG000', 'lowerLimit': '0.58', 'upperLimit': '1.29'}, {'value': '1.27', 'groupId': 'OG001', 'lowerLimit': '0.92', 'upperLimit': '1.75'}, {'value': '0.68', 'groupId': 'OG002', 'lowerLimit': '0.54', 'upperLimit': '0.86'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)', 'description': 'All participant deaths were recorded', 'unitOfMeasure': 'Events per 100 person-years of follow-up', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Person years of follow-up', 'denomUnitsSelected': 'Person years of follow-up', 'populationDescription': 'Intention-to-Treat analysis included follow-up until the end of the follow-up period for the cohort, regardless of whether or not raltegravir or other drugs were discontinued.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Raltegravir Cohort Only', 'description': 'Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union). 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These participants contributed data to the Historical Cohort and the Concurrent Cohort.'}, {'id': 'FG004', 'title': 'Concurrent Cohort Only', 'description': 'Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. These participants contributed data only to the Concurrent Cohort.'}, {'id': 'FG005', 'title': 'Concurrent and Raltegravir Cohorts Only', 'description': 'Participants with HIV-1 infection who 1) started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort, and 2) started raltegravir on or after 21 December 2007 and had at least 1 month prospective follow-up in the Raltegravir Cohort. These participants contributed data to the Concurrent Cohort and the Raltegravir Cohort.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '656'}, {'groupId': 'FG001', 'numSubjects': '296'}, {'groupId': 'FG002', 'numSubjects': '1681'}, {'groupId': 'FG003', 'numSubjects': '631'}, {'groupId': 'FG004', 'numSubjects': '3199'}, {'groupId': 'FG005', 'numSubjects': '154'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '656'}, {'groupId': 'FG001', 'numSubjects': '296'}, {'groupId': 'FG002', 'numSubjects': '1681'}, {'groupId': 'FG003', 'numSubjects': '631'}, {'groupId': 'FG004', 'numSubjects': '3199'}, {'groupId': 'FG005', 'numSubjects': '154'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'The analyses in this study are based on data collected from a cohort of HIV-1-infected participants in a setting of routine clinical care in Europe (EuroSIDA Cohort Study). Participants could contribute data to more than one cohort, but no overlap in follow-up time was allowed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '656', 'groupId': 'BG000'}, {'value': '296', 'groupId': 'BG001'}, {'value': '1681', 'groupId': 'BG002'}, {'value': '631', 'groupId': 'BG003'}, {'value': '3199', 'groupId': 'BG004'}, {'value': '154', 'groupId': 'BG005'}, {'value': '6617', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Raltegravir Cohort Only', 'description': 'Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union). Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in this cohort. 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These participants contributed data only to the Historical Cohort.'}, {'id': 'BG003', 'title': 'Historical and Concurrent Cohorts', 'description': 'Participants with HIV-1 infection who 1) started a new antiretroviral drug as part of a cART regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in the Historical Cohort, and 2) started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. These participants contributed data to the Historical Cohort and the Concurrent Cohort.'}, {'id': 'BG004', 'title': 'Concurrent Cohort Only', 'description': 'Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. These participants contributed data only to the Concurrent Cohort.'}, {'id': 'BG005', 'title': 'Concurrent and Raltegravir Cohorts Only', 'description': 'Participants with HIV-1 infection who 1) started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort, and 2) started raltegravir on or after 21 December 2007 and had at least 1 month prospective follow-up in the Raltegravir Cohort. These participants contributed data to the Concurrent Cohort and the Raltegravir Cohort.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000', 'lowerLimit': '44', 'upperLimit': '55'}, {'value': '49', 'groupId': 'BG001', 'lowerLimit': '44', 'upperLimit': '55'}, {'value': '44', 'groupId': 'BG002', 'lowerLimit': '39', 'upperLimit': '50'}, {'value': '47', 'groupId': 'BG003', 'lowerLimit': '41', 'upperLimit': '53'}, {'value': '42', 'groupId': 'BG004', 'lowerLimit': '34', 'upperLimit': '50'}, {'value': '50', 'groupId': 'BG005', 'lowerLimit': '45', 'upperLimit': '57'}, {'value': '44', 'groupId': 'BG006', 'lowerLimit': '37', 'upperLimit': '51'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '422', 'groupId': 'BG002'}, {'value': '174', 'groupId': 'BG003'}, {'value': '873', 'groupId': 'BG004'}, {'value': '27', 'groupId': 'BG005'}, {'value': '1744', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '480', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '1259', 'groupId': 'BG002'}, {'value': '457', 'groupId': 'BG003'}, {'value': '2326', 'groupId': 'BG004'}, {'value': '127', 'groupId': 'BG005'}, {'value': '4873', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6617}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2014-03-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-11', 'studyFirstSubmitDate': '2010-02-26', 'resultsFirstSubmitDate': '2015-06-15', 'studyFirstSubmitQcDate': '2010-03-01', 'lastUpdatePostDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-08-17', 'studyFirstPostDateStruct': {'date': '2010-03-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Malignancy', 'timeFrame': 'Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)', 'description': 'All-type malignancy, including both Acquired Immune Deficiency Syndrome (AIDS)-defining and non-AIDS-defining malignancy, was evaluated. Only the first occurrence of any malignancy type was counted for each participant.'}, {'measure': 'Incidence of Clinically Important Hepatic Events', 'timeFrame': 'Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)', 'description': 'Clinically important hepatic events were defined as either 1) hepatic encephalopathy (stage III or IV), or 2) discontinuation of raltegravir use where liver toxicity was listed as the reason for discontinuation.'}, {'measure': 'Incidence of Lipodystrophy', 'timeFrame': 'Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)', 'description': 'Lipodystrophy events were defined as the first report for either 1) loss of fat from extremities, buttocks, or face, or 2) accumulation of fat in abdomen, neck, breasts, or other defined location.'}, {'measure': 'Incidence of All-Cause Mortality', 'timeFrame': 'Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)', 'description': 'All participant deaths were recorded'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'antiretroviral treatment', 'HIV Cohort', 'Treatment'], 'conditions': ['HIV-1 Infections']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/study.html?id=0518-058&kw=0518-058&tab=access', 'type': 'CSR Synopsis'}], 'references': [{'pmid': '28984429', 'type': 'RESULT', 'citation': 'Cozzi-Lepri A, Zangerle R, Machala L, Zilmer K, Ristola M, Pradier C, Kirk O, Sambatakou H, Fatkenheuer G, Yust I, Schmid P, Gottfredsson M, Khromova I, Jilich D, Flisiak R, Smidt J, Rozentale B, Radoi R, Losso MH, Lundgren JD, Mocroft A; EuroSIDA Study Group. Incidence of cancer and overall risk of mortality in individuals treated with raltegravir-based and non-raltegravir-based combination antiretroviral therapy regimens. HIV Med. 2018 Feb;19(2):102-117. doi: 10.1111/hiv.12557. Epub 2017 Oct 6.'}], 'seeAlsoLinks': [{'url': 'http://www.encepp.eu/encepp/viewResource.htm?id=18914', 'label': 'EUPAS Register (EUPAS17912)'}]}, 'descriptionModule': {'briefSummary': 'The main objective of the study is to monitor health outcomes associated with antiretroviral drugs in a population of HIV-infected patients.', 'detailedDescription': 'Time Perspective: Retrospective and Prospective'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults 16 years old and older in the EuroSIDA database', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 16 years old and older with HIV-1\n\nExclusion Criteria:\n\n* Subjects will be excluded if they have no prospective follow up'}, 'identificationModule': {'nctId': 'NCT01078233', 'briefTitle': 'Observational Data Analysis in EuroSIDA (MK-0518-058)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Observational Safety Data Analysis From Routine Follow-up in the EuroSIDA Study of Patients Treated With Raltegravir in a Five-Year Post Authorization Period', 'orgStudyIdInfo': {'id': '0518-058'}, 'secondaryIdInfos': [{'id': '2010_020', 'type': 'OTHER', 'domain': 'Merck'}, {'id': 'EP08025.005', 'type': 'OTHER', 'domain': 'Merck'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Raltegravir Cohort', 'description': 'Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union) and had at least 1 month prospective follow-up in the Raltegravir Cohort. Participants from the Historical Cohort and Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.'}, {'label': 'Historical Cohort', 'description': 'Participants with HIV-1 infection who started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Historical Cohort.'}, {'label': 'Concurrent Cohort', 'description': 'Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'EuroSIDA Coordinating Centre, Copenhagen HIV Programme (CHIP)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}