{"study_desc":{"title_statement":{"idno":"FRESH-PEF60024-en","IDno":{"metadata_no":[{"agency":"PEF","code":"60024"},{"agency":"FReSH","code":"FRESH-PEF60024"}]},"title":"Cohort of HIV-infected patients who began treatment with protease inhibitor in 1997-1999. Follow-up over 4 years on the long-term effects linked with adherence and tolerance (COPILOT).","alternate_title":"ANRS CO8 APROCO-COPILOTE"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Catherine;LEPORT","firstname":"Catherine","lastname":"LEPORT","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01kv58h76","role":"organisation id"},{"title":"SIREN","uri":"180089385","role":"organisation id"},{"uri":"069413916","role":"pi id","title":"IdRef"}],"email":"","affiliationName":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","PILabo":"ANRS \/ LABORATOIRE DE RECHERHE EN PATHOLOGIE INFECTIEUSE","isContact":false}],"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":"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)"},{"name":"F. HOFFMANN-LA ROCHE AG","extlink":[{"title":"SIREN","uri":"775752140"},{"title":"ROR","uri":"https:\/\/ror.org\/01mqmer16"}]},{"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":"unexpected events"},{"keyword":"Observed health events"},{"keyword":"serious adverse events"},{"keyword":"cardiovascular risk factors"}],"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":"D055552"}]},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"General objective: To investigate determinants for long-term effects of adherence and tolerance to highly active antiretroviral drugs, in relation to patients infected with HIV-1 who were treated for the first time under a protease inhibitor in 1997-99. Secondary objectives: - to determine the part that host genetic polymorphisms play in the progression of the infection and onset of serious adverse events - to investigate viral load and antiretroviral resistance in plasma cell compartments in relation to antiretroviral concentrations over time.","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":"Individuals","universe":"{\"level_sex_clusion_I\":[{\"value\":\"Male\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008297\"}},{\"value\":\"Female\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D005260\"}}],\"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 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