Cytomegalovirus ViraemiaQ-CMVNCT02370758
Cell Mediated Immunity for Secondary Prophylaxis in CMV SOT Patients
A study testing Valganciclovir or Ganciclovir in people with Cytomegalovirus Viraemia, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cytomegalovirus Viraemia
- What is being tested?
- Valganciclovir or Ganciclovir
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2014to 16 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Known ganciclovir-resistant CMV
- Known intolerance to valganciclovir or ganciclovir
- Unable to comply with protocol
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, Toronto General Hospital, Multi-Organ Transplant
Toronto, Ontario, M5G2N2
About this study
Official title: Cell Mediated Immunity as a Guide for Secondary Prophylaxis in SOT Patients With CMV Infection
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.
Read the 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.
- Conditions
- Cytomegalovirus Viraemia
- Being tested
- Valganciclovir or Ganciclovir
- Keywords
- Quantiferon-CMV, Quantiferon-Monitor, Solid Organ Transplants, CMV Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valganciclovir or GanciclovirDrug
| Study group | Role | What they receive |
|---|---|---|
| Low CMV CMI | Active comparator | 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. Receives: Drug: Valganciclovir or Ganciclovir |
| High CMV CMI | No intervention | Patients that show high levels of cell-mediated immunity against CMV will have their antiviral therapy (oral Valganciclovir or Intravenous Ganciclovir) stopped. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virologic recurrence or disease recurrence
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startNov 2014
- Primary completionSep 2016
- Study completion16 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus ViraemiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Atul Humar, MD, Principal investigator, University Health Network, TorontoDeepali Kumar, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370758
- Sponsor's protocol ID
- UHN-CMV-001
- Acronym
- Q-CMV
- Status last verified
- Sep 2017
- First submitted
- 18 Feb 2015
- Last updated
- 21 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell Mediated Immunity as a Guide for Secondary Prophylaxis in SOT Patients With CMV Infection
- ClinicalTrials.gov ID
- NCT02370758
- Acronym / sponsor ID
- Q-CMV / UHN-CMV-001
- Conditions
- Cytomegalovirus Viraemia
- Keywords
- Quantiferon-CMV, Quantiferon-Monitor, Solid Organ Transplants, CMV Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- 16 Jun 2017 (actual)
- First posted
- 25 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low CMV CMI | Active comparator | Drug: Valganciclovir or GanciclovirPatients 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. |
| High CMV CMI | No intervention | –Patients that show high levels of cell-mediated immunity against CMV will have their antiviral therapy (oral Valganciclovir or Intravenous Ganciclovir) stopped. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Known ganciclovir-resistant CMV
- Known intolerance to valganciclovir or ganciclovir
- Unable to comply with protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valganciclovir or Ganciclovir | Drug | Low CMV CMI |
Primary outcome
Virologic recurrence or disease recurrence
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atul Humar, MD principal investigator
University Health Network, Toronto
Deepali Kumar, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valganciclovir or Ganciclovir in people with Cytomegalovirus Viraemia, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virologic recurrence or disease recurrence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2017.