{"doc_desc":{"title":"Observational study of the sociodemographic characteristics of patients infected with HIV B subtype versus HIV non-B subtype and having recently started their first course of antiretroviral treatment.","idno":"FRESH-PEF1252-en","producers":[{"name":"Isabelle COHEN-CODAR","affiliation":"ABBVIE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF1252-en","IDno":{"metadata_no":[{"agency":"PEF","code":"1252"},{"agency":"FReSH","code":"FRESH-PEF1252"}]},"title":"Observational study of the sociodemographic characteristics of patients infected with HIV B subtype versus HIV non-B subtype and having recently started their first course of antiretroviral treatment.","alternate_title":"BINOME"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Isabelle;COHEN-CODAR","PILabo":"ABBVIE","affiliationName":"ABBVIE","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"750775660","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"No"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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":"anti-retroviral drug treatment (ARV)"},{"keyword":"viral subtype"},{"keyword":"Protease inhibitors (PI)"},{"keyword":"non-nucleoside reverse transcriptase inhibitors (NNRTI)"},{"keyword":"HIV"}],"topics":[{"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":"Socio-demographic and economic determinants: Employment","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"Describe and compare the socio-demographic characteristics of patients infected with an HIV-1 of subtype B (group 1) compared to non-B (group 2) treated with a first anti-retroviral drug treatment. Compare according to the HIV subtype the stage of the disease (clinical, viro-immunology, co-morbidities) at the time treatment is initiated, compare between the 2 groups (B and non-B) the conditions for taking the treatment and the perception by the patient of the therapy and of its effects. Identification of any correlation between these latter parameters and the change in the disease between the initiation and the first line ARV and the inclusion in the cohort: - change in the viral load (VL) according to the ARV treatment (PI, NNRTI) and of the HIV subtype (B or non-B), of the CD4, - any occurrence of clinical events, - any changes in treatments and reasons.","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":"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    \"level_age_clusion_I\": [\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            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Age > 18 years, obtaining of written consent for the collection of this personal data, patient infected by the HIV-1 virus, patient coming to consult for the first or second routine follow-up visit (i.e. 1 to 4 months) after the initiation of the ARV treatment, genotype available when the treatment is initiated.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health 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 care consumption and services\r\nQuality of life\/health perception"}]},"method":{"data_collection":{"time_method":"One-time cross-sectional study","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\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","response_rate":"304"},"method_notes":"Observational Study","study_class":"Completed study","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"To be defined\",\"extLink\":[]}"},"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":"21-02-2011","lastUpdatedAuto":null,"lastUpdatedManual":"01-07-2018","isContributorPI":"No","contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/21233637"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industry"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industry"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"No","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"\"Patient\" observation sheets completed by the physician and sent by the post to the company in charge of data management. Visual analog scales completed by the patient and remitted to the physician and then sent to the company in charge of data management.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Metropolitan France"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"biological monitoring of the HIV infection","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}