{"doc_desc":{"title":"Etude longitudinale sur des patients infect\u00e9s par le VIH-2 vivant en France: histoire naturelle de l'infection","idno":"FRESH-PEF60089-fr","producers":[{"name":"Sophie MATHERON","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60089-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60089"},{"agency":"FReSH","code":"FRESH-PEF60089"}]},"title":"Etude longitudinale sur des patients infect\u00e9s par le VIH-2 vivant en France: histoire naturelle de l'infection","alternate_title":"ANRS C05 VIH-2"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Sophie;MATHERON","firstname":"Sophie","lastname":"MATHERON","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id"},{"title":"SIREN","uri":"267500452","role":"organisation id"}],"email":"","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","PILabo":"APHP \/ MALADIES INFECTIEUSES ET TROPICALES, HOPITAL BICHAT-CLAUDE BERNARD","isContact":false}],"oth_id":[{"name":"r\u00e9seau de cohortes : ACHIEV2E (14 centres europ\u00e9ens et 2 centres d'Afrique de l'Ouest),","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (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"}]},{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261"},{"title":"SIREN","uri":"180036048"}]}]},"distribution_statement":{"contact":[{"name":"Julie;LONBOGARDI","lastname":"LONBOGARDI","firstname":"Julie","type":"contact","email":"bph.cohorte_co5_vih-2@dif.credim.u-bordeaux.fr","affiliationName":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01kv58h76","role":"organisation id","title":"ROR"},{"uri":"180089385","role":"organisation id","title":"SIREN"}]},{"name":"Linda;WITTKOP","lastname":"WITTKOP","firstname":"Linda","type":"contact","email":"linda.wittkop@inserm.fr","affiliationName":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01kv58h76","role":"organisation id","title":"ROR"},{"uri":"180089385","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"VIH-2"},{"keyword":"histoire naturelle"},{"keyword":"infection VIH"},{"keyword":"sida"}],"topics":[{"topic":"Infectiologie","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":"Certaines maladies infectieuses ou parasitaires","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1435254666","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux : Addictions","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux : Autres","vocab":"health determinant"},{"topic":"Syst\u00e8mes de soins et acc\u00e8s aux soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Objectif principal \u00c9tudier l'infection par VIH-2 chez les patients adultes suivis en France. Objectifs secondaires - D\u00e9crire les caract\u00e9ristiques \u00e9pid\u00e9miologiques et cliniques des participants infect\u00e9s par VIH-2, et les caract\u00e9ristiques immuno-virologiques de l\u2019infection. - \u00c9tudier la progression clinique et immunologique de l\u2019infection par VIH-2 et les facteurs pronostiques de cette \u00e9volution. - Etudier la r\u00e9ponse (clinique, immuno-virologique) au traitement antir\u00e9troviral et contribuer \u00e0 l\u2019identification des strat\u00e9gies et combinaisons antir\u00e9trovirales les plus adapt\u00e9es aux particularit\u00e9s de l\u2019infection. - Permettre une \u00e9valuation des pratiques de prise en charge des participants suivis dans les centres hospitaliers fran\u00e7ais - Fournir une banque de donn\u00e9es clinico-biologiques et de pr\u00e9l\u00e8vements permettant la r\u00e9alisation d\u2019\u00e9tudes fondamentales sur l\u2019infection par VIH-2.","abstract":"","coll_dates":[{"start":"1994-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\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\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Crit\u00e8res d\u2019inclusion : -Infection par VIH-2 seulement, diagnostiqu\u00e9e par ELISA, confirm\u00e9e par Western-Blot, -Suivi en consultation ou en hospitalisation dans un des centres investigateurs , -Age sup\u00e9rieur ou \u00e9gal \u00e0 18 ans, -Suivi prolong\u00e9 possible, r\u00e9sidence en France pr\u00e9vue pour au moins un an, -Consentement du participant \u00e0 participer, -Prise en charge en ALD (Affection de Longue Dur\u00e9e) possible pour le participant, ou aide m\u00e9dicale d\u2019\u00e9tat (AME), ou d\u00e9claration d'obtention d'AME au moment de l'inclusion.  Crit\u00e8res de \",\n    \"clusion_E\": \"infection par VIH-1  -double s\u00e9ropositivit\u00e9 VIH-1 + VIH-2  \"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Contr\u00f4les de coh\u00e9rence apr\u00e8s la saisie des donn\u00e9es. Monitorage \u00e0 distance et sur site: retour au dossier source pour la gestion et la v\u00e9rification des donn\u00e9es. Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[{"sourceCitation":{"titlStmt":{"titl":""},"holdings":"","notes":{"subject":"source purpose","value":""}},"srcOrig":["Base m\u00e9dico-administrative"]}],"target_sample_size":"[1000-10000[ individus","response_rate":"1185 participants inclus, 540 en cours de suivi"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"Utilisation possible des donn\u00e9es par des \u00e9quipes acad\u00e9miques Utilisation possible des donn\u00e9es par des industriels","conditions":"Condition d'acc\u00e8s temporelles pour les recherches acad\u00e9miques (collaborations pour des \u00e9tudes satellites virologiques, immunologiques, et des essais th\u00e9rapeutiques) Condition d'acc\u00e8s collaborations contractuelles (ANRS) industrielles possibles","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"04-02-2021","isContributorPI":false,"contributorName":"Julie LONBOGARDI","contributorAffiliation":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"List of publications in HAL","link":"http:\/\/tinyurl.com\/Hal-ANRS-CO5-HIV-2"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":true},"collaborations":{"networkConsortium":true},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"donn\u00e9es saisies dans un cahier d'observation \u00e9lectronique","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":true},"geographicalCoverage":{"geoDetail":"Cohorte multicentrique fran\u00e7aise (117 centres hospitaliers jusqu'au 30\/10\/2019 puis 34 centres)"},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l\u2019inclusion puis tous les 6mois. Informations recueillies : poids, tension art\u00e9rielle, \u00e9v\u00e9nements classants aux stades B ou C de la classification des CDC, autres \u00e9v\u00e9nements cliniques et, pour les femmes, grossesse et m\u00e9nopause.","biologicalDataDetails":"Pr\u00e9l\u00e8vement sanguin (donn\u00e9es hematologiques, immunologiques, biochimiques, virologiques)","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[""]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}