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

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.