CompletedNot Applicable

Cell Mediated Immunity for Secondary Prophylaxis in CMV SOT Patients

Canada32 participantsStarted 2014-11

Plain-language summary

This study will evaluate whether a test for Cytomegalovirus (CMV) specific cell-mediated immunity can be used to determine whether patients who complete a course of therapy for CMV viremia need secondary antiviral prophylaxis. Subjects that have negative CMV CMI will receive antiviral prophylaxis for 2 months and those with positive CMV CMI will have their prophylaxis stopped.

Who can participate

SexALL

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Inclusion Criteria: * Adult solid organ transplant (SOT) recipient on at least one immunosuppressive medication * Starting therapy for new onset asymptomatic CMV viremia OR starting therapy for new onset CMV disease * CMV viral load ≥ 1000 IU/mL Exclusion Criteria: * Known ganciclovir-resistant CMV * Known intolerance to valganciclovir or ganciclovir * Unable to comply with protocol

What they're measuring

Virologic recurrence or disease recurrence

Timeframe: 6 months

Trial details

NCT IDNCT02370758

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-09

View on ClinicalTrials.gov More Cytomegalovirus Viraemia trials