{"doc_desc":{"title":"Etude transversale de patients infect\u00e9s par un VIH de sous-type soit B soit non-B, ayant r\u00e9cemment d\u00e9but\u00e9 un premier traitement anti-r\u00e9troviral : caract\u00e9ristiques socio-d\u00e9mographiques - FRAN06-004","idno":"FRESH-PEF1252-fr","producers":[{"name":"Isabelle COHEN-CODAR","affiliation":"ABBVIE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF1252-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"1252"},{"agency":"FReSH","code":"FRESH-PEF1252"}]},"title":"Etude transversale de patients infect\u00e9s par un VIH de sous-type soit B soit non-B, ayant r\u00e9cemment d\u00e9but\u00e9 un premier traitement anti-r\u00e9troviral : caract\u00e9ristiques socio-d\u00e9mographiques - FRAN06-004","alternate_title":"BINOME"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Isabelle;COHEN-CODAR","firstname":"Isabelle","lastname":"COHEN-CODAR","type":"investigator","extlink":[{"title":"SIREN","uri":"750775660","role":"organisation id"}],"email":"","affiliationName":"ABBVIE","PILabo":"ABBVIE","isContact":false}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"ABBOTT FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05wz8pk64","role":"sponsor id"},{"title":"SIREN","uri":"602950206","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"ABBOTT FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05wz8pk64"},{"title":"SIREN","uri":"602950206"}]}]},"distribution_statement":{"contact":[{"name":"","type":"contact"}]},"study_info":{"keywords":[{"keyword":"traitement anti-r\u00e9troviral (ARV)"},{"keyword":"sous-type viral"},{"keyword":"Inhibiteurs de la prot\u00e9ase (IP)"},{"keyword":"Inhibiteurs nucl\u00e9osidiques de la transcriptase inverse (NNRTI)"},{"keyword":"VIH"}],"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":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques : Emploi","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"D\u00e9crire et comparer les caract\u00e9ristiques socio-d\u00e9mographiques des patients infect\u00e9s par un VIH-1 de sous-type B (groupe 1) versus non-B (groupe 2) trait\u00e9s par un premier traitement anti-r\u00e9troviral. Comparer en fonction du sous-type de VIH le stade de la maladie (clinique, viro-immunologie, co-morbidit\u00e9s) au moment de la mise sous traitement, comparer entre les 2 groupes (B et non-B) les conditions de prise du traitement et de la perception par le patient de la th\u00e9rapeutique et de ses effets. Identification d\u2019une \u00e9ventuelle corr\u00e9lation entre ces derniers param\u00e8tres et l\u2019\u00e9volution de la maladie entre l\u2019initiation de la 1er ligne ARV et l\u2019inclusion dans la cohorte : - \u00e9volution de la charge virale (CV) en fonction du traitement ARV (IP, NNRTI) et du sous-type de VIH (B ou non-B), des CD4, - survenue \u00e9ventuelle d\u2019\u00e9v\u00e8nements cliniques, - changement \u00e9ventuels de traitements et motifs.","abstract":"","coll_dates":[{"start":"2007-01-01","end":"2008-01-01"}],"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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Age > 18 ans, obtention du consentement \u00e9crit pour la collecte des donn\u00e9es personnelles, patient infect\u00e9 par le virus VIH-1, patient venant consulter pour la premi\u00e8re ou deuxi\u00e8me visite de suivi de routine (soit 1 \u00e0 4 mois) apr\u00e8s l\u2019initiation du traitement ARV, g\u00e9notype disponible lors de la mise sous traitement.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nConsommation de soins\/services de sant\u00e9\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"method":{"data_collection":{"time_method":"Etude transversale non r\u00e9p\u00e9t\u00e9e","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":[],"target_sample_size":"< 500 individus","response_rate":"304"},"method_notes":"Etude observationnelle","study_class":"\u00c9tude compl\u00e9t\u00e9e","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"A d\u00e9finir\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","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":"21-02-2011","lastUpdatedAuto":null,"lastUpdatedManual":"01-07-2018","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/21233637"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":false,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Fiches d\u2019observations \u00ab patients \u00bb compl\u00e9t\u00e9es par le m\u00e9decin et envoy\u00e9 par courrier \u00e0 la soci\u00e9t\u00e9 en charge de la gestion des donn\u00e9es. Echelles visuelles analogiques compl\u00e9t\u00e9es par le patient et remis au m\u00e9decin puis envoy\u00e9e \u00e0 la soci\u00e9t\u00e9 en charge de la gestion des donn\u00e9es.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France m\u00e9tropolitaine"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"suivi biologique de l'infection VIH","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}