{"doc_desc":{"title":"VISCONTI cohort : International-Viro-Immunologic Sustained CONtrol after Treatment Interruption","idno":"FRESH-PEF8455-en","producers":[{"name":"Asier SAEZ-CIRION","affiliation":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8455-en","IDno":{"metadata_no":[{"agency":"PEF","code":"8455"},{"agency":"FReSH","code":"FRESH-PEF8455"}]},"title":"VISCONTI cohort : International-Viro-Immunologic Sustained CONtrol after Treatment Interruption","alternate_title":"ANRS EP 47 VISCONTI"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Laurent;HOCQUELOUX","PILabo":"CENTRE HOSPITALIER R\u00c9GIONAL D'ORL\u00c9ANS","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE D ORLEANS (CHUO)","extlink":[{"title":"ORCID","uri":"0000-0002-2264-4822","role":"pi id"},{"title":"IdRef","uri":"255536321","role":"pi id"},{"title":"SIREN","uri":"264500091","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"laurent.hocqueloux@chr-orleans.fr","isContact":"Yes"}],"oth_id":[{"name":""}],"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"}]}]},"distribution_statement":{"contact":[{"name":"Asier;SAEZ-CIRION","email":"asier.saez-cirion@pasteur.fr","type":"contact","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":"Laurent;HOCQUELOUX","email":"laurent.hocqueloux@chr-orleans.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE D ORLEANS (CHUO)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/04yvax419","role":"organisation id","title":"ROR"},{"uri":"264500091","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"primary infection"},{"keyword":"HIV treatment"},{"keyword":"functional remission"},{"keyword":"genetic characteristics"},{"keyword":"seropositivity"},{"keyword":"immune system"},{"keyword":"HIV"}],"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":"http:\/\/id.nlm.nih.gov\/mesh\/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":"http:\/\/id.nlm.nih.gov\/mesh\/D055552"}]},{"topic":"HIV disease clinical stage 1 without mention of tuberculosis or malaria","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/574153866","title":"CIM-11"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"I-VISCONTI is a multicenter, multidisciplinary (clinicians, virologists, immunologists and epidemiologists) pathophysiologic study designed to explore the virological and immunological mechanisms responsible for sustained control of HIV-1 infection after ART interruption in adults or children who started treatment very early in the primary infection or during the chronic phase. I-VISCONTI also aims to identify markers that could be used to identify patients who could reasonably interrupt their antiretroviral treatment.","abstract":"","coll_dates":[{"start":"2013-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        },\n        {\n            \"value\": \"Other\",\n            \"concept\": {\n                \"vocab\": [],\n                \"vocabURI\": []\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Child, Preschool (2 to 5 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n            }\n        },\n        {\n            \"value\": \"Child (6 to 12 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\n        {\n            \"value\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patients infected with HIV-1 and not co-infected with HIV-2 - Whatever is the age at the time of HIV-1-infection - Plasma HIV RNA > 2000 copies\\\/mL before initiation of antiretroviral therapy - Treatment started during the primary infection (as defined by symptoms associated with seroconversion, as confirmed by a first negative ELISA and\\\/or an incomplete P24-positive Western blot), at the time of delivery for children or during the chronic phase of infection, and maintained for at least 12 months in both cases. - Control of viral load after antiretroviral treatment interruption: patients must have at least two available viral load assays after stopping antiretroviral therapy. All viral loads must be <400 copies\\\/mL for 12 months or more after stopping antiretroviral therapy, with the possible exception of one blip (one viral load above 400 copies\\\/mL between two viral loads <400 copies\\\/mL at least one month apart from the blip; in this case at least three viral load assays will be required). The last plasma viral load value at the time of inclusion must always be <400 copies\\\/mL\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Biological data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality\r\nHealth care consumption and services"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","response_rate":"14 patients (primary infection)."},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"24-03-2014","lastUpdatedAuto":null,"lastUpdatedManual":"25-10-2017","isContributorPI":"No","contributorName":"Asier SAEZ-CIRION","contributorAffiliation":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"Liste des publications dans Pubmed","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=ANRS+AND+visconti"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Yes"},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Metropolitan France."},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Blood test.","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}