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Cell Mediated Immunity for Secondary Prophylaxis in CMV SOT Patients (Q-CMV)

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ClinicalTrials.gov Identifier: NCT02370758
Recruitment Status : Completed
First Posted : February 25, 2015
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief 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.

Condition or disease Intervention/treatment Phase
Cytomegalovirus Viraemia Drug: Valganciclovir or Ganciclovir Not Applicable

Detailed Description:

Cytomegalovirus (CMV) is the most important infection in transplant patients and it is a common cause of illness in patients who have undergone a transplant. Serious infections due to CMV can affect many parts of the body including the lungs, the gut, and the liver; when CMV infection becomes serious enough to cause symptoms, it is called CMV disease. Some patients require treatment while others will clear the virus on their own.

QuantiFERON-CMV (QFT-CMV) is a blood test that measures CMV-specific cell-mediated immunity. This test was able to predict that patients with low cell-mediated immunity are at greater risk for developing CMV disease. In this study, QFT-CMV will be used to make a decision regarding CMV treatment. The QFT-CMV test will be performed at the first detection of CMV, at end of antiviral therapy and one month post-therapy. The end-of-therapy results will be available to clinicians and study investigators within one week of collection. Based on the result, a decision will be made to continue with prolonged antiviral therapy. Patients that show weak cell-mediated immunity against CMV will be given secondary antiviral prophylaxis, while patients with good cell-mediated immunity will have their therapy stopped. Patients will continue to be monitored three months after the last QFT-CMV test for recurrent CMV viremia.

This study will also attempt to evaluate the predictive value of the QuantiFERON-Monitor (QFT-Monitor) assay. QFT-Monitor is a recently developed non-pathogen specific immune assay: it is based on immune activation of both innate and adaptive immunity. The investigators hypothesize that stimulation of both the innate and adaptive immunity may predict global immune function and also be predictive of CMV reactivation. The investigators plan to perform the QFT-Monitor assay in parallel to the QFT-CMV test to determine the test characteristics and cut-off values in predicting global immune function. This test will be collected and tested in batches. Therefore, the results will not influence clinical decisions.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cell Mediated Immunity as a Guide for Secondary Prophylaxis in SOT Patients With CMV Infection
Actual Study Start Date : November 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : June 16, 2017


Arm Intervention/treatment
Active Comparator: Low CMV CMI
Patients that show low levels of cell-mediated immunity against CMV will have their antiviral therapy (oral Valganciclovir or Intravenous Ganciclovir) continued for an additional 2 months at half dose.
Drug: Valganciclovir or Ganciclovir
No Intervention: High CMV CMI
Patients that show high levels of cell-mediated immunity against CMV will have their antiviral therapy (oral Valganciclovir or Intravenous Ganciclovir) stopped.



Primary Outcome Measures :
  1. Virologic recurrence or disease recurrence [ Time Frame: 6 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02370758


Locations
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Canada, Ontario
University Health Network, Toronto General Hospital, Multi-Organ Transplant
Toronto, Ontario, Canada, M5G2N2
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Atul Humar, MD University Health Network, Toronto
Principal Investigator: Deepali Kumar, MD University Health Network, Toronto

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02370758     History of Changes
Other Study ID Numbers: UHN-CMV-001
First Posted: February 25, 2015    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017

Keywords provided by University Health Network, Toronto:
Quantiferon-CMV
Quantiferon-Monitor
Solid Organ Transplants
CMV Disease

Additional relevant MeSH terms:
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Valganciclovir
Viremia
Virus Diseases
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Ganciclovir
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action