[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636803":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":45,"centralContacts":50,"locations":59,"responsibleParty":133,"collaborators":137,"id":145,"slug":146,"hasResults":147,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":147,"sex":153,"minAge":154,"maxAge":21,"enrollmentInfo":155,"targetDuration":21,"studyType":158,"phases":159,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":173,"whyStopped":21,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":183},{"fullName":5,"class":6},"University of Lausanne Hospitals","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"50% reduction in the dose of MPA for a duration of minimum 21 days","EXPERIMENTAL","with standard antiviral therapy",[13],"Drug: 50% reduction in the dose of MPA",{"label":15,"type":10,"description":11,"interventionNames":16},"switch of MPA to everolimus with adapted dose of tacrolimus, for a duration of at least 56 days",[17],"Drug: Switch from MPA to a mammalian target of rapamycin inhibitor (mTORi), together with an adapted dose of tacrolimus",{"label":19,"type":20,"description":21,"interventionNames":22},"Standard antiviral therapy without modulation of immunosuppression","ACTIVE_COMPARATOR",null,[23],"Drug: standard antiviral therapy along with maintenance of their initial immunosuppressive therapy.",[25,33,39],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","50% reduction in the dose of MPA","50% reduction in the dose of MPA with standard antiviral therapy",[9],[31,32],"Mycophenolic acid","Mycophenolate mofetil",{"type":26,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Switch from MPA to a mammalian target of rapamycin inhibitor (mTORi), together with an 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5484","elisa.ruiz-arabi@chuv.ch",[60,81,95,112],{"facility":61,"status":21,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Centre hospitalier universitaire Bordeaux (CHU Bordeaux)","Bourdeaux","Talence Cedex","33404","France","FR",{"type":68,"coordinates":69},"Point",[70,71],5.13611,44.58582,{"lat":71,"lon":70},[74,78],{"name":75,"role":52,"phone":76,"phoneExt":21,"email":77},"Hannah Kaminski, Professor, MD, PhD","+33 05 56 79 56 79","hannah.kaminski@chu-bordeaux.fr",{"name":79,"role":80,"phone":21,"phoneExt":21,"email":21},"Lionel Couzi, Professor MD, PhD","SUB_INVESTIGATOR",{"facility":82,"status":21,"city":83,"state":83,"zip":84,"country":65,"countryCode":66,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Centre hospitalier universitaire Toulouse (CHU 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Vaud","1011","Switzerland","CH",{"type":68,"coordinates":120},[121,122],6.63282,46.516,{"lat":122,"lon":121},[125,126,127,129,131],{"name":47,"role":52,"phone":53,"phoneExt":21,"email":54},{"name":56,"role":52,"phone":57,"phoneExt":21,"email":58},{"name":128,"role":80,"phone":21,"phoneExt":21,"email":21},"Dela Golshayan, Professor, MD PhD",{"name":130,"role":80,"phone":21,"phoneExt":21,"email":21},"Julien Vionnet, MD, PhD",{"name":132,"role":80,"phone":21,"phoneExt":21,"email":21},"Patrick Yerly, MD",{"type":134,"investigatorFullName":135,"investigatorTitle":136,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"SPONSOR_INVESTIGATOR","Oriol Manuel","Associated Professor",[138,141,143],{"name":139,"class":140},"Centre Hospitalier Universitaire Bordeaux","UNKNOWN",{"name":142,"class":140},"Centre Hospitalier Universitaire de Toulouse, FRANCE",{"name":144,"class":6},"Hospital Vall d'Hebron","100636803","phase-4-horus-cytomegalovirus-open-proof-of-concept-exploratory-trial-100636803",false,"NCT07570433","HORUS-Cytomegalovirus Open Proof-of-concept Exploratory Trial","HORUS-Cytomegalovirus Open Proof-of-concept Exploratory Trial (HORUS-COPE): An International Proof-of-concept Clinical Trial on Modulation of Immunosuppressive Regimen in Solid-organ Transplant Recipients With Cytomegalovirus Infection.","HORUS-COPE","Inclusion Criteria:\n\n* Clinically stable adult patients (aged 18 years or older) who have received a solid organ transplant (e.g., kidney, liver, heart, lung, pancreas) and developed clinically significant CMV infection as determined by positive CMV PCR.\n* On maintenance therapy of tacrolimus, MPA, +\u002F- steroids.\n* Informed consent signed.\n\nExclusion Criteria:\n\n* Active acute graft rejection or significant graft dysfunction requiring modification of the current immunosuppressive regimen, in the opinion of the investigator.\n* Receipt of more than 72 hours of antiviral therapy for CMV infection prior to enrolment, before randomization, including valganciclovir and\u002For IV ganciclovir therapy\n* Known intolerance or hypersensitivity to mTOR inhibitors or to any component of the everolimus formulation.\n* Any medical condition that constitutes a contraindication to everolimus use, as judged by the investigator.\n* Additional exclusion criteria for French sites:\n\n  * Patient not affiliated to the French social security system\n  * Patient under legal protection (guardianship, curatorship).","ALL","18 Years",{"count":156,"type":157},100,"ESTIMATED","INTERVENTIONAL",[160],"PHASE4","Cytomegalovirus (CMV) remains a significant cause of morbidity and mortality following organ transplantation.\n\nCell-mediated immunity plays a crucial role in controlling CMV replication after transplantation. Immune monitoring involves the use of immune biomarkers to dynamically estimate the risk of CMV replication. This approach allows for the individualization of preventive and therapeutic strategies, improving patient outcomes.\n\nThe HORUS-COPE trial is designed to assess the effect of immune modulation on CMV replication kinetics and to explore the performance of a selected immune signature during antiviral therapy for CMV infection to stratify patients based on their risk of not responding to immune modulation.",[163],"CMV Infection",[165,166,167,168,38,169,170,171,172],"solid organ transplantation","CMV","cytomegalovirus","immunosuppression","mTORi","MPA","infection","immune signature","NOT_YET_RECRUITING","2026-04-29",{"date":176,"type":177},"2026-05-06","ACTUAL",{"date":179,"type":157},"2026-04",{"date":181,"type":157},"2028-03",{"name":135,"class":6},4]