{"study_desc":{"title_statement":{"idno":"FRESH-PEF3626-en","IDno":{"metadata_no":[{"agency":"PEF","code":"3626"},{"agency":"FReSH","code":"FRESH-PEF3626"}]},"title":"Inter-cohort and clinical centers collaboration of subjects co-infected by human immunodeficiency virus and hepatitis C","alternate_title":"ANRS C013 HEPAVIH"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"}]},"authoring_entity":[{"name":"Laure;ESTERLE","firstname":"Laure","lastname":"ESTERLE","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"uri":"0000-0002-1017-1327","role":"pi id","title":"ORCID"},{"uri":"144303140","role":"pi id","title":"IdRef"}],"email":"","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","PILabo":"Inserm \/ INSERM, U1219, Centre de Recherche Inserm Bordeaux Publique Health, \u00e9quipe Morpheus, CMG-EC","isContact":false},{"name":"Dominique;SALMON","firstname":"Dominique","lastname":"SALMON","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05f82e368","role":"organisation id"},{"title":"SIREN","uri":"130025737","role":"organisation id"},{"uri":"19920814X","role":"pi id","title":"IdRef"}],"email":"dominique.salmon@aphp.fr","affiliationName":"UNIVERSITE PARIS CITE","PILabo":"Assistance Publique des H\u00f4pitaux de Paris - H\u00f4pitaux Paris Centre, Universit\u00e9 Paris Descartes \/ Services des Maladies Infectieuses et Tropicales","isContact":true},{"name":"Philippe;SOGNI","firstname":"Philippe","lastname":"SOGNI","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05f82e368","role":"organisation id"},{"title":"SIREN","uri":"130025737","role":"organisation id"},{"uri":"076006824","role":"pi id","title":"IdRef"}],"email":"philippe.sogni@aphp.fr","affiliationName":"UNIVERSITE PARIS CITE","PILabo":"Assistance Publique des H\u00f4pitaux de Paris - H\u00f4pitaux Paris Centre, Universit\u00e9 Paris Descarte, Inserm \/ Service d'H\u00e9patologie","isContact":true}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"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"}]},{"name":"F. HOFFMANN-LA ROCHE AG","extlink":[{"title":"SIREN","uri":"775752140"},{"title":"ROR","uri":"https:\/\/ror.org\/01mqmer16"}]},{"name":"GLAXOSMITHKLINE (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00z1h3j87"},{"title":"SIREN","uri":"592052146"}]},{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261"},{"title":"SIREN","uri":"180036048"}]},{"name":"JANSSEN CILAG (JANSSEN - JOHNSON & JOHNSON - JOHNSON & JOHNSON INNOVATIVE MEDICINE)","extlink":[{"title":"SIREN","uri":"562033068"}]},{"name":"MERCK SANTE","extlink":[{"title":"SIREN","uri":"572028033"}]}]},"distribution_statement":{"contact":[{"name":"Linda;WITTKOP","lastname":"WITTKOP","firstname":"Linda","type":"contact","email":"linda.wittkop@u-bordeaux.fr","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"}]},{"name":"Dominique;SALMON","lastname":"SALMON","firstname":"Dominique","type":"contact","email":"dominique.salmon@aphp.fr","affiliationName":"UNIVERSITE PARIS CITE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05f82e368","role":"organisation id","title":"ROR"},{"uri":"130025737","role":"organisation id","title":"SIREN"}]},{"name":"Philippe;SOGNI","lastname":"SOGNI","firstname":"Philippe","type":"contact","email":"philippe.sogni@aphp.fr","affiliationName":"UNIVERSITE PARIS CITE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05f82e368","role":"organisation id","title":"ROR"},{"uri":"130025737","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Adults"},{"keyword":"disease carriers"},{"keyword":"cured"},{"keyword":"treatment"},{"keyword":"co-infection"}],"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":"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":"D055552"}]},{"topic":"HIV disease clinical stage 2 without mention of tuberculosis or malaria","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1575370503","title":"CIM-11"}]},{"topic":"Viral hepatitis","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/985510409","title":"CIM-11"}]},{"topic":"Behavioral determinants","vocab":"health determinant"}],"purpose":"Short term: - Describe patient's characteristics - Analyze factors associated to a treatment of hepatitis C: beginning of the treatment, continuation or stop of the treatment. - Validate the field performance of not-invasive markers of hepatic fibrosis. Mid-term: - Realize an observational study of the evolution of hepatitis during an anti-VHC treatment, in an antiviral situation - Study the clinical and biological tolerance to the different treatments. - Study the impact of the observance of the treatment anti HIV and the life quality of patients. Long term: Study the natural history of chronic hepatitis, in particular at the stage of cirrhosis. - Analyze the factors associated to the evolution to fibrosis, to a decompensated hepatic disease or an hepatocellular carcinoma. - Evaluate the effects of antiretroviral agents on the evolution of not-treated hepatitis - Study the potential interactions between different virus of hepatitis","abstract":"","coll_dates":[{"start":"2005-01-01","end":"2018-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\"level_sex_clusion_I\":[{\"value\":\"Male\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008297\"}},{\"value\":\"Female\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D005260\"}},{\"value\":\"Other\",\"concept\":{\"vocab\":[],\"vocabURI\":[]}}],\"level_age_clusion_I\":[{\"value\":\"Young Adult (19 to 24 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D055815\"}},{\"value\":\"Adult (25 to 44 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000328\"}},{\"value\":\"Middle Aged (45 to 64 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008875\"}},{\"value\":\"Aged (65 to 79 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000368\"}}],\"level_type_clusion_I\":\"Patients population\",\"level_type_clusion_other\":\"\",\"clusion_I\":\"Adults infected by HIV virus carriers of VHC or cured after anti-VHC treatment, or spontaneously healed without anti-VHC treatment or benefiting from an anti-VHC tritherapies.\",\"clusion_E\":\"\"}","data_kind":"['Clinical data','Paraclinical data (non-biological)','Paraclinical data (non-biological) : Imaging','Biological data','Participant-reported health data']","quality_statement":{"standards":[{"name":"['---']","committee":"","governance":""}],"other_quality_statement":"['Data utilization possible for academic teams and for industrials. 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Temporary access condition : project accepted by the scientific committee","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}","notes":""},"dataset_use":{"restrictions":"Temporary access condition : project accepted by the scientific committee","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""}}},"additional":{"versionLang":"en","originLang":"en","autoTranslation":false,"status":"Imported","creationDate":"09-05-2012","lastUpdatedManual":"07-08-2019","isContributorPI":"","contributorName":"Dominique SALMON","contributorAffiliation":"UNIVERSITE PARIS CITE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Industry","Industry","Public (France)","Industry","Industry"],"otherFundingAgentType":["","","","","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":true},"collaborations":{"networkConsortium":""},"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":"Self-questionnaire: filled from a paper questionnaire. Interviews: filled from a paper questionnaire .Clinical examination: manual data entry .Biological examination: manual data entry","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"French multi-centers cohort (28 centers)"},"dataTypes":{"clinicalDataDetails":"Clinical examination at inclusion and during the follow-up. 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