{"doc_desc":{"title":"Cohorte primo-infection","idno":"FRESH-PEF60076-fr","producers":[{"name":"Asma ESSAT","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60076-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60076"},{"agency":"FReSH","code":"FRESH-PEF60076"}]},"title":"Cohorte primo-infection","alternate_title":"ANRS CO6 PRIMO"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"}]},"authoring_entity":[{"type":"investigator","name":"C\u00e9cile;GOUJARD","PILabo":"APHP \/ SERVICE M\u00c9DECINE INTERNE - H\u00d4PITAL BIC\u00caTRE","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ORCID","uri":"0000-0002-7956-0822","role":"pi id"},{"title":"IdRef","uri":"099027291","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"cecile.goujard@aphp.fr","isContact":"Oui"},{"type":"investigator","name":"Asma;ESSAT","PILabo":"INSERM \/ CESP INSERM U1018","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"278871119","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"RNSR","uri":"201019083D","role":"labo id"}],"email":"","isContact":"Non"},{"type":"investigator","name":"Laurence;MEYER","PILabo":"INSERM - Institut National de Sant\u00e9 et Recherche \/ CESP INSERM U1018","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ORCID","uri":"0000-0002-6113-936X","role":"pi id"},{"title":"IdRef","uri":"091570530","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"RNSR","uri":"200616425G","role":"labo id"}],"email":"laurence.meyer@inserm.fr","isContact":"Oui"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"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"},{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"sponsor id"},{"title":"SIREN","uri":"180036048","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":"C\u00e9cile;GOUJARD","email":"cecile.goujard@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"}]},{"name":"Laurence;MEYER","email":"laurence.meyer@inserm.fr","type":"contact","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id","title":"ROR"},{"uri":"180036048","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"lipodystrophies"},{"keyword":"pathologies graves"},{"keyword":"\u00e9v\u00e9nements de sant\u00e9"},{"keyword":"d\u00e9c\u00e8s"}],"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":"Maladie par le virus de l'immunod\u00e9ficience humaine sans mention de tuberculose ni de paludisme","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1508081745","title":"CIM-11"}]},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux : Autres","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","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 g\u00e9n\u00e9ral : Suivre dans le temps des patients infect\u00e9s depuis moins de 3 mois par le VIH-1. 1. Am\u00e9liorer les connaissances physio-pathologiques sur la primo-infection \u00e0 VIH et plus particuli\u00e8rement - \u00c9tude des m\u00e9canismes immunitaires impliqu\u00e9s pr\u00e9cocement apr\u00e8s la contamination ; - Cin\u00e9tique de la r\u00e9plication virale et constitution des r\u00e9servoirs cellulaires \u00e0 un stade pr\u00e9coce ; - Relations entre marqueurs virologiques et dynamique de la r\u00e9ponse immunitaire ; - Impact du sous-type viral, du tropisme et des mutations de r\u00e9sistance sur la progression de la maladie et la r\u00e9ponse au traitement ; - Etude de sous-groupes de patients particuliers : contr\u00f4leurs spontan\u00e9s ou apr\u00e8s arr\u00eat de traitement, suivis depuis la primo-infection ; sujets porteurs d\u2019all\u00e8les HLA particuliers. 2. Evaluer l\u2019impact des traitements pr\u00e9coces, transitoires ou prolong\u00e9s, versus les traitements diff\u00e9r\u00e9s, sur le pronostic \u00e0 long terme des patients pris en charge d\u00e8s la primo-infection, en termes d\u2019activation \/ inflammation et de baisse des r\u00e9servoirs viraux. 3. Contribuer \u00e0 documenter l\u2019\u00e9pid\u00e9miologie de l\u2019infection VIH et plus particuli\u00e8rement : - Modes de transmission ; - Comportements sexuels des sujets apr\u00e8s le diagnostic ; - Evolution calendaire de la diversit\u00e9 des souches virales transmises (r\u00e9sistances aux ARV et sous-types) ; - Evolution calendaire du niveau des marqueurs en primo-infection. 4. Contribuer aux recommandations nationales de prise en charge th\u00e9rapeutique, \u00e9valuer leur mise en \u0153uvre. 5. Utiliser les donn\u00e9es observationnelles de la cohorte pour l\u2019\u00e9laboration d\u2019essais th\u00e9rapeutiques en primo- infection et assurer le suivi post-essai.","abstract":"","coll_dates":[{"start":"1996-01-01","end":"2022-01-01"}],"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            \"value\": \"Autre\",\n            \"concept\": {\n                \"vocab\": [],\n                \"vocabURI\": []\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\": \"Les crit\u00e8res d\u2019inclusion sont: 1. Une primo-infection symptomatique ou asymptomatique d\u00e9finie par l\u2019un des crit\u00e8res suivants : -ARN-VIH1 positif ou Antig\u00e9n\u00e9mie p24 positive + ELISA n\u00e9gatif (Ac-\\\/Ag p24-): Confirm\u00e9 par un 2\u00e8me ARN-VIH1 positif dans les 6 semaines pr\u00e9c\u00e9dant l\u2019inclusion -ARN-VIH1 positif ou Antig\u00e9n\u00e9mie p24 positive + ELISA positif Ac-\\\/p24+ dans les 6 semaines pr\u00e9c\u00e9dant l\u2019inclusion -ARN-VIH1 positif ou Antig\u00e9n\u00e9mie p24 positive + ELISA positif* et WB-VIH1 n\u00e9gatif dans les 6 semaines pr\u00e9c\u00e9dant l\u2019inclusion -ARN-VIH1 positif ou Antig\u00e9n\u00e9mie p24 positive ou ELISA positif* + WB-VIH-1 incomplet (absence d\u2019anti-p34 et\\\/ou anti-p68) dans les 6 semaines pr\u00e9c\u00e9dant l\u2019inclusion -Test ELISA positif avec un test ELISA n\u00e9gatif dans les trois mois pr\u00e9c\u00e9dents. * : ELISA Ac+\\\/Ag p24+ ou ELISA Ac+\\\/Ag p24- 2. Un \u00e2ge sup\u00e9rieur ou \u00e9gal \u00e0 15 ans au moment de l\u2019inclusion. 3. Un traitement antir\u00e9troviral non initi\u00e9 avant la premi\u00e8re visite (\u00e0 l\u2019exception de prises d\u2019antir\u00e9troviraux en prophylaxie pr\u00e9 ou post-exposition). 4. D\u2019\u00eatre affili\u00e9 ou b\u00e9n\u00e9ficiaire d\u2019un r\u00e9gime de s\u00e9curit\u00e9 sociale\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence apr\u00e8s la saisie des donn\u00e9es informatiques. Gestion des donn\u00e9es manquantes par retour au dossier source. 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\r\nConsommation de soins\/services de sant\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\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"2523 jusqu'en octobre 2020"},"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","conditions":"","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":"11-12-2020","isContributorPI":"Non","contributorName":"C\u00e9cile GOUJARD","contributorAffiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)","Public (France)"],"otherSponsorType":["",""]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":"Oui"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Auto-questionnaire : saisie \u00e0 partir d\u2019un questionnaire papier. Examens cliniques : \u00e9tape manuscrite. Examens biologiques : \u00e9tape manuscrite","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Cohorte multicentrique fran\u00e7aise (99 centres)"},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l\u2019inclusion et au cours du suivi (M1, M3, M6, M12 puis tous les ans) Informations recueillies lors de l'examen clinique : suivi classique VIH : num\u00e9ration des lymphocytes CD4 et CD8 ; quantification de l'ARN-VIH plasmatique ; g\u00e9notypage des souches pour la r\u00e9sistance aux ARV, prise en charge th\u00e9rapeutique","biologicalDataDetails":"Type de pr\u00e9l\u00e8vements r\u00e9alis\u00e9s : Sang","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}