HORUS-Cytomegalovirus Open Proof-of-concept Exploratory Trial
ConditionCMV Infection
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorOriol Manuel
About this trial
Cytomegalovirus (CMV) remains a significant cause of morbidity and mortality following organ transplantation.
Cell-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.
The 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.
Eligibility criteria
Qualifiers
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.
On maintenance therapy of tacrolimus, MPA, +/- steroids.
Informed consent signed.
Disqualifiers
Active acute graft rejection or significant graft dysfunction requiring modification of the current immunosuppressive regimen, in the opinion of the investigator.
Receipt of more than 72 hours of antiviral therapy for CMV infection prior to enrolment, before randomization, including valganciclovir and/or IV ganciclovir therapy
Known intolerance or hypersensitivity to mTOR inhibitors or to any component of the everolimus formulation.
Any medical condition that constitutes a contraindication to everolimus use, as judged by the investigator.
Trial design
Treatments tested in this trial
- 50% reduction in the dose of MPA
- Switch from MPA to a mammalian target of rapamycin inhibitor (mTORi), together with an adapted dose of tacrolimus
- standard antiviral therapy along with maintenance of their initial immunosuppressive therapy.
Treatment groups
100 Participants
are divided into 3 treatment groupsSponsors and collaborators
Oriol Manuel
Lead sponsor
University of Lausanne Hospitals
Sponsor institution
Centre Hospitalier Universitaire Bordeaux
Collaborator
Centre Hospitalier Universitaire de Toulouse, FRANCE
Collaborator
Hospital Vall d'Hebron
Collaborator
Source ClinicalTrials.gov