{"doc_desc":{"title":"Cohorte de patients infect\u00e9s par le VIH ayant d\u00e9but\u00e9 un traitement avec inhibiteur de prot\u00e9ase en 1997-1999. suivi au-del\u00e0 de 4 ans des effets \u00e0 long terme li\u00e9s \u00e0 l'observance et \u00e0 la tol\u00e9rance (copilote).","idno":"FRESH-PEF60024-fr","producers":[{"name":"Catherine LEPORT","affiliation":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60024-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60024"},{"agency":"FReSH","code":"FRESH-PEF60024"}]},"title":"Cohorte de patients infect\u00e9s par le VIH ayant d\u00e9but\u00e9 un traitement avec inhibiteur de prot\u00e9ase en 1997-1999. suivi au-del\u00e0 de 4 ans des effets \u00e0 long terme li\u00e9s \u00e0 l'observance et \u00e0 la tol\u00e9rance (copilote).","alternate_title":"ANRS CO8 APROCO-COPILOTE"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Catherine;LEPORT","PILabo":"ANRS \/ LABORATOIRE DE RECHERHE EN PATHOLOGIE INFECTIEUSE","affiliationName":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"069413916","role":"pi id"},{"title":"SIREN","uri":"180089385","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"Non"}],"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"}],"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":"ABBOTT FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05wz8pk64"},{"title":"SIREN","uri":"602950206"}]},{"name":"BOEHRINGER INGELHEIM INTERNATIONAL GMBH","extlink":[{"title":"SIREN","uri":"508241882"}]},{"name":"BRISTOL MYERS SQUIBB PHARMA FRANCE S.A","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/013b57229"},{"title":"SIREN","uri":"380059956"}]},{"name":"COLLEGE DES UNIVERSITAIRES DE MALADIES INFECTIEUSES ET TROPICALES (CMIT)","extlink":[]},{"name":"F. HOFFMANN-LA ROCHE AG","extlink":[{"title":"SIREN","uri":"775752140"}]},{"name":"GILEAD SCIENCES","extlink":[{"title":"SIREN","uri":"391360971"}]},{"name":"GLAXOSMITHKLINE (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00z1h3j87"},{"title":"SIREN","uri":"592052146"}]},{"name":"PFIZER (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02c9yny10"},{"title":"SIREN","uri":"433623550"}]},{"name":"SIDACTION (ECS)","extlink":[{"title":"SIREN","uri":"398945543"}]}]},"distribution_statement":{"contact":[{"name":"","type":"contact"}]},"study_info":{"keywords":[{"keyword":"\u00e9v\u00e9nements ind\u00e9sirables graves"},{"keyword":"\u00e9v\u00e9nements inattendus"},{"keyword":"\u00e9v\u00e9nements de sant\u00e9 observ\u00e9s"},{"keyword":"facteurs de risque cardiovasculaire"}],"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 biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Objectif g\u00e9n\u00e9ral : \u00c9tudier les d\u00e9terminants, li\u00e9s notamment \u00e0 l'observance et \u00e0 la tol\u00e9rance, des effets \u00e0 long terme des antir\u00e9troviraux hautement actifs dans le contexte de la pratique de la prise en charge chez les patients infect\u00e9s par le VIH-1 mis pour la 1re fois sous inhibiteur de protease en 1997-99. Objectifs secondaires : - d\u00e9terminer la part des polymorphismes g\u00e9n\u00e9tiques de l'h\u00f4te dans la progression de l'infection et la survenue d'effets ind\u00e9sirables graves - \u00e9tudier la charge virale et la r\u00e9sistance aux antir\u00e9troviraux dans le compartiment plasmatique cellulaire, en relation avec les concentrations des antir\u00e9troviraux au cours du temps.","abstract":"","coll_dates":[{"start":"2003-01-01","end":"2009-01-01"}],"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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patients inclus dans la cohorte Aproco (adultes infect\u00e9s par le VIH1 avec 1e prescription d'inhibiteur de prot\u00e9ase en 1997-99), suivis dans Aproco quatre ans apr\u00e8s leur inclusion initiale, suivis dans un des services volontaires pour participer a la prolongation du suivi, ayant donn\u00e9 leur consentement \u00e9crit.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es paracliniques (hors biologiques) : Anthropom\u00e9trie']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Gestion des donn\u00e9es manquantes par retour au dossier source']"}},"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\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"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":"717: Copilote 1281: Aproco"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study 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