Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2026-01-22 @ 10:55 AM
Study NCT ID:
NCT02874118
Status:
COMPLETED
Last Update Posted:
2023-04-07
First Post:
2016-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Search for Fragility Indicators Among People Aged 50+ With Chronic HIV Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 510}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-06', 'studyFirstSubmitDate': '2016-08-17', 'studyFirstSubmitQcDate': '2016-08-17', 'lastUpdatePostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of frailed patient among the HIV population folloxed in southeastern France area', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Frail in HIV Population']}, 'descriptionModule': {'briefSummary': 'The frailty and frail elderly was defined in 2001 by Fried as a physiological state of heightened vulnerability to external shocks. 5 criteria for classifying the elderly in 3 categories: frail, pre-frail and not frail. The prevalence of frailty in the general population was estimated to be 7%, 10% and 20% for over 65 years and 45% for over 85 years. This concept is explored in some chronic diseases, in order to prevent the loss of autonomy and tailor the treatment. In the carrier population of HIV, a North American retrospective study showed the frailty syndrome manifested as early as 10 years before, than in the general population. Furthermore various studies show in this specific population, increased incidence of diseases linked to age, suggesting an accelerated and premature aging.\n\nobjectives: The objective of this study is to determine the prevalence of frailty defined Fried syndrome in a population of subjects aged 50 and over Holders of chronic HIV infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with HIV and followed in the southeastern France area\n\nExclusion Criteria:\n\n* In patient HIV infected patient\n* HIV patient disabled (spastic)\n* HIV infected for less than a year'}, 'identificationModule': {'nctId': 'NCT02874118', 'acronym': 'Visage 3', 'briefTitle': 'Search for Fragility Indicators Among People Aged 50+ With Chronic HIV Infection', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'orgStudyIdInfo': {'id': '2011-41'}, 'secondaryIdInfos': [{'id': '2011-A01679-32', 'type': 'OTHER', 'domain': 'Ansm'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HIV Patient population over 50 years old', 'interventionNames': ['Behavioral: Fried scale for frailty assessement']}], 'interventions': [{'name': 'Fried scale for frailty assessement', 'type': 'BEHAVIORAL', 'armGroupLabels': ['HIV Patient population over 50 years old']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13354', 'city': 'Marseille', 'country': 'France', 'facility': 'Assistance Publique Hôpitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'Ureielle DESALBRES', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique Hôpitaux de Marseille'}, {'name': 'Nathalie PETIT, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique Hôpitaux de Marseille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}