Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
Study NCT ID:
NCT03969550
Status:
COMPLETED
Last Update Posted:
2019-05-31
First Post:
2019-05-29
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Do CCR5 Antagonists Improve the Overall Survival of Patients With AIDS-related Progressive Multifocal Leucoencephalopathy?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D007968', 'term': 'Leukoencephalopathy, Progressive Multifocal'}, {'id': 'D054019', 'term': 'Immune Reconstitution Inflammatory 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'}, {'id': 'D018792', 'term': 'Encephalitis, Viral'}, {'id': 'D020805', 'term': 'Central Nervous System Viral Diseases'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D000069544', 'term': 'Infectious Encephalitis'}, {'id': 'D027601', 'term': 'Polyomavirus Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D004660', 'term': 'Encephalitis'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D056784', 'term': 'Leukoencephalopathies'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-29', 'studyFirstSubmitDate': '2019-05-29', 'studyFirstSubmitQcDate': '2019-05-29', 'lastUpdatePostDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': '8 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Maraviroc', 'John Cunningham virus (JCV)', 'Immune reconstitution inflammatory syndrome (IRIS)', 'Combined antiretroviral treatment (cART)', 'Overall survival (OS)'], 'conditions': ['AIDS', 'Progressive Multifocal Leucoencephalopathy (PML)']}, 'descriptionModule': {'briefSummary': 'Progressive multifocal leucoencephalopathy (PML) is a demyelinating disease caused by John Cunningham virus (JCV) reactivation. Numerous molecules have been overstated because there were inaccurately tested in non-rigorous clinical trial.\n\nThe objective is to draw lessons from repeatedly false hopes of unconfirmed PML treatments that might contribute to prescribing ineffective drugs on claimed efficacy in case reports or small series and by failing to respect the need for clinical trial evaluation before authorizing their widespread use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with AR-PML, exposed or not to maraviroc, as part of combined antiretroviral treatment (cART).', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with AR-PML\n* Diagnosed between January 2008 and December 2015\n* Followed in one of the four University Hospitals' Infectious Diseases Departments\n\nExclusion Criteria:"}, 'identificationModule': {'nctId': 'NCT03969550', 'briefTitle': 'Do CCR5 Antagonists Improve the Overall Survival of Patients With AIDS-related Progressive Multifocal Leucoencephalopathy?', 'organization': {'class': 'NETWORK', 'fullName': 'Fondation Ophtalmologique Adolphe de Rothschild'}, 'officialTitle': 'Do CCR5 Antagonists Improve the Overall Survival of Patients With AIDS-related Progressive Multifocal Leucoencephalopathy?', 'orgStudyIdInfo': {'id': '29305436'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Measure of overall survival', 'type': 'OTHER', 'description': 'Measure of overall survival among AR-PML (AIDS-related PML) patients, exposed or not to maraviroc (MVC), and immune reconstitution inflammatory syndrome (IRIS) onset.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Ophtalmologique Adolphe de Rothschild', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}