{"doc_desc":{"title":"Cohort of HIV-Infected Patients Treated with Interleukin-2 (IL-2). Study of Tolerance and Long-Term Clinical and Biological Progression of Immunotherapy Treatment.","idno":"FRESH-PEF60058-en","producers":[{"name":"Jean-Pierre ABOULKER","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60058-en","IDno":{"metadata_no":[{"agency":"PEF","code":"60058"},{"agency":"FReSH","code":"FRESH-PEF60058"}]},"title":"Cohort of HIV-Infected Patients Treated with Interleukin-2 (IL-2). Study of Tolerance and Long-Term Clinical and Biological Progression of Immunotherapy Treatment.","alternate_title":"ANRS CO14 IL-2"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Yves;LEVY","PILabo":"IMRB (Institut Mondor de Recherche \/ Inserm U955","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ORCID","uri":"0000-0002-5549-6256","role":"pi id"},{"title":"IdRef","uri":"26731650X","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"RNSR","uri":"200919261B","role":"labo id"}],"email":"yves.levy@aphp.fr","isContact":"Yes"},{"type":"investigator","name":"Jean-Pierre;ABOULKER","PILabo":"INSERM SC10 jp.aboulker@vjf.inserm.fr","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"RNSR","uri":"201019111J","role":"labo id"}],"email":"","isContact":"No"},{"type":"investigator","name":"Dominique;COSTAGLIOLA","PILabo":"INSERM U720","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ORCID","uri":"0000-0003-0765-0869","role":"pi id"},{"title":"IdRef","uri":"109189108","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"No"}],"oth_id":[{"name":"Other associated cohorts: French hospital database (FHDH) on HIV infection.","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01kv58h76","role":"sponsor id"},{"title":"SIREN","uri":"180089385","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01kv58h76"},{"title":"SIREN","uri":"180089385"}]}]},"distribution_statement":{"contact":[{"name":"Yves;LEVY","email":"yves.levy@aphp.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Neoplasia"},{"keyword":"autoimmune disease"},{"keyword":"systemic"},{"keyword":"specific"},{"keyword":"clinical progression"},{"keyword":"immunovirology"},{"keyword":"cardiovascular events"}],"topics":[{"topic":"Clinical immunology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/7a3cf568-46ba-4840-be8f-f22fc030139f"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D000486"}]},{"topic":"Infectious disease medicine","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D055552"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"General objective: to study the long-term clinical tolerance of IL-2 treatment administered to patients infected with HIV. In particular, to monitor the occurrence of non-Hodgkin's lymphoma, neoplasia, systematic or specific autoimmune diseases and cardiovascular events, including venous or arterial thrombosis. Secondary objective: to investigate clinical progression (occurrence of events related to HIV and AIDS classification) and biological progression (CD4 and CD8 immune response and viral load) of HIV infection.","abstract":"","coll_dates":[{"start":"2007-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"HIV-infected individuals over 18 years of age that have received at least one course of IL-2 in the ANRS trial or authorisation for temporary use, who have given signed consent and are affiliated members or beneficiaries of a social security scheme.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Biological data','Paraclinical data (non-biological) : Anthropometry']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Request for consistency after data is processed electronically Missing data is managed by returning to source file or third party']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Medical-administrative database (patients, health insurance\/mutual insurance) Disease and death registry']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[500-1000[ individuals","response_rate":"613 Number of required subjects : [500-1000]"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"Data may be used by academic teams. Data may be used by industrial teams.","conditions":"For academic teams: Access in accordance with agreement from sponsor and Scientific Council. For indistrial teams: Access in accordance with agreement from sponsor, their Board of Directors and the cohort Scientific Council under contract.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"22-07-2014","isContributorPI":"No","contributorName":"Yves LEVY","contributorAffiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":"Yes"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Clinical examination: manual input","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Multicentric cohort throughout France (20 centres)"},"dataTypes":{"clinicalDataDetails":"Clinical examination at baseline and during follow-up. Frequency of examination: 4 years Information collected during clinical examination: IL2 tolerance, clinical and immuno-virological monitoring of HIV infection.","biologicalDataDetails":"Type of samples taken: Blood","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}