[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572103":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":16,"locations":25,"responsibleParty":56,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":10,"enrollmentInfo":73,"targetDuration":10,"studyType":76,"phases":10,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":86,"whyStopped":10,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"IRCCS San Raffaele","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Subjects living with HIV switching to long acting therapy",null,"The study will include subjects living with HIV, followed at the San Luigi Center (Infectious Diseases), IRCCS Ospedale San Raffaele in Milan, Integrated Infectious Risk Management Department, Policlinico S. Orsola-Malpighi in Bologna, and the Department of Mental and Physical Health and Medicine prevention, University of Campania L. Vanvitelli of Naples, who agree to the switch from the current antiretroviral regimen which includes drugs active on HIV\u002FHBV to long acting therapy.",[13],{"name":14,"affiliation":5,"role":15},"Antonella Castagna, Prof, MD","PRINCIPAL_INVESTIGATOR",[17,21],{"name":14,"role":18,"phone":19,"phoneExt":10,"email":20},"CONTACT","+39 0226433473","castagna.antonella@hsr.it",{"name":22,"role":18,"phone":23,"phoneExt":10,"email":24},"Elisabetta Carini, Mrs","+390226437934","carini.elisabetta@hsr.it",[26,38,47],{"facility":27,"status":10,"city":28,"state":10,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":10},"IRCCS Azienda Ospedaliero-Universitaria di Bologna","Bologna","40138","Italy","IT",{"type":33,"coordinates":34},"Point",[35,36],11.33875,44.49381,{"lat":36,"lon":35},{"facility":39,"status":10,"city":40,"state":10,"zip":41,"country":30,"countryCode":31,"cosmosGeoPoint":42,"geoPoint":46,"contacts":10},"IRCCS San Raffaele O.U. Infectious Diseases","Milan","20127",{"type":33,"coordinates":43},[44,45],9.18951,45.46427,{"lat":45,"lon":44},{"facility":48,"status":10,"city":49,"state":10,"zip":50,"country":30,"countryCode":31,"cosmosGeoPoint":51,"geoPoint":55,"contacts":10},"Università Luigi Vanvitelli della Campania","Naples","80138",{"type":33,"coordinates":52},[53,54],14.26811,40.85216,{"lat":54,"lon":53},{"type":15,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Castagna Antonella","Prof",[60,61],{"name":27,"class":6},{"name":62,"class":6},"University of Campania Luigi Vanvitelli","100572103","occult-hepatitis-b-virus-infection-and-hbv-reactivation-after-switching-to-long-acting-therapy-in-patients-with-hiv-1-100572103",false,"NCT06728917","Occult Hepatitis B Virus Infection and HBV Reactivation After Switching to Long Acting Therapy in Patients With HIV-1","Occult Hepatitis B Virus Infection and HBV Reactivation After Switching to Long Acting Therapy in Patients Living With HIV-1","OBILART","Inclusion Criteria:\n\n* Age \\> 18 years\n* Informed consent to participate in the study\n* HIV infection\n* Stable antiretroviral therapy (ART) in the six months prior to enrollment without virological failure defined by HIV-RNA\\>50 copies\u002FmL in at least two consecutive determinations\n* Positive HBV anti-core antibodies (HBcAb) in the absence of hepatitis B surface antigen (HBsAg)\n* Absence of mutations associated with resistance to integrase inhibitors (INSTIs) and reverse transcriptase inhibitors (NNRTIs) by HIV genotypic resistance testing\n* CD4 Nadir \\>200 cells\u002Fmm3\n\nExclusion Criteria:\n\n* Any contraindications to the use of one or more long-acting drugs\n* Non-expression or withdrawal of informed consent to participate in the study\n* Pregnancy\n* Lack of HIV genotypic resistance testing\n* Virological failure (HIV-RNA \\>50 copies\u002FmL in at least 2 consecutive determinations) in the 6 months prior to enrollment\n* Therapeutic interruptions in the six months prior to enrollment, excluding interruptions lasting less than a month due to tolerability\n* CD4 Nadir =\\\u003C200 cells\u002Fmm3\n* Presence of biochemical signs of hepatocellular necrosis (AST, ALT \\> normal values as indicated in laboratory tests).\n* Cirrhosis and\u002For fibrosis score \\>F3 assessed by transient elastography (FibroScan).","ALL","18 Years",{"count":74,"type":75},50,"ESTIMATED","OBSERVATIONAL","The primary objective of the present project will be to investigate the risk of HBV reactivation (from virological reactivation to overt HBV infection) in HIV-1 carriers with occult HBV infection (OBI, is characterized by the absence of surface antigenemia, HBsAg negativity, with the presence of HBV-core antibody, HBcAb) and switching from antiretroviral therapy (ART) including nucleos(t)ides to long-acting formulation.",[79,80],"HBV (Hepatitis B Virus)","HIV Infection",[82,83,84,85],"Occult hepatitis B virus infection","long acting therapy","people living with HIV-1","HBV reactivation","NOT_YET_RECRUITING","2024-12-10",{"date":89,"type":90},"2024-12-11","ACTUAL",{"date":92,"type":75},"2025-01-20",{"date":94,"type":75},"2025-11-30",{"name":5,"class":6},3]