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

Primary Purpose

Cytomegalovirus Viraemia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Valganciclovir or Ganciclovir
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cytomegalovirus Viraemia focused on measuring Quantiferon-CMV, Quantiferon-Monitor, Solid Organ Transplants, CMV Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Health Network, Toronto General Hospital, Multi-Organ Transplant

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Low CMV CMI

High CMV CMI

Arm Description

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.

Patients that show high levels of cell-mediated immunity against CMV will have their antiviral therapy (oral Valganciclovir or Intravenous Ganciclovir) stopped.

Outcomes

Primary Outcome Measures

Virologic recurrence or disease recurrence

Secondary Outcome Measures

Full Information

First Posted
February 18, 2015
Last Updated
September 20, 2017
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02370758
Brief Title
Cell Mediated Immunity for Secondary Prophylaxis in CMV SOT Patients
Acronym
Q-CMV
Official Title
Cell Mediated Immunity as a Guide for Secondary Prophylaxis in SOT Patients With CMV Infection
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
June 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Viraemia
Keywords
Quantiferon-CMV, Quantiferon-Monitor, Solid Organ Transplants, CMV Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low CMV CMI
Arm Type
Active Comparator
Arm Description
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.
Arm Title
High CMV CMI
Arm Type
No Intervention
Arm Description
Patients that show high levels of cell-mediated immunity against CMV will have their antiviral therapy (oral Valganciclovir or Intravenous Ganciclovir) stopped.
Intervention Type
Drug
Intervention Name(s)
Valganciclovir or Ganciclovir
Primary Outcome Measure Information:
Title
Virologic recurrence or disease recurrence
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atul Humar, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Deepali Kumar, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network, Toronto General Hospital, Multi-Organ Transplant
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2N2
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Cell Mediated Immunity for Secondary Prophylaxis in CMV SOT Patients

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