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Cell Mediated Immunity and the Prediction of CMV Infection In Solid Organ Transplant Recipients

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ClinicalTrials.gov Identifier: NCT00436384
Recruitment Status : Completed
First Posted : February 19, 2007
Last Update Posted : April 16, 2008
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
University Health Network, Toronto

Study Description
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Brief Summary:
Cytomegalovirus (CMV) 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. Since transplant recipients are at risk for CMV or have evidence of infection with CMV, they are given an antiviral drug (usually ganciclovir or valganciclovir). Despite this, there are a chance that CMV infection may cause problems in the future. The purpose of this study is to assess how well patients'immune systems responds to the CMV virus, so that in the future it may be possible to predict which patients are at highest risk of CMV.

Condition or disease Intervention/treatment
Transplant Procedure: Monitoring-blood samples drawn for CMV testing

Study Design
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Study Type : Observational
Enrollment : 150 participants
Official Title: Cell Mediated Immunity and the Prediction of CMV Infection In Solid Organ Transplant Recipients
Study Start Date : November 2005
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

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Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients who fulfill the following criteria are eligible for inclusion.

    • CMV D+/R- liver, kidney and heart recipient
    • CMV R+ liver,kidney and heart recipients who have received thymoglobulin induction therapy.
    • D+/R- and R+ lung transplant recipients.
    • Able to give written informed consent
    • Are willing and able to comply with the protocol
    • Age >=18 years

Exclusion Criteria:

  • Patient unwilling or unable to give informed consent
Contacts and Locations
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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): NCT00436384


Locations
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2N2
Sponsors and Collaborators
University Health Network, Toronto
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Atul Humar, MD University Health Network, Toronto
Principal Investigator: Deepali Kumar, MD University Health Network, Toronto
More Information
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ClinicalTrials.gov Identifier: NCT00436384     History of Changes
Other Study ID Numbers: 05-0265-AE
First Posted: February 19, 2007    Key Record Dates
Last Update Posted: April 16, 2008
Last Verified: February 2007

Keywords provided by University Health Network, Toronto:
liver transplant
lung transplant
kidney transplant
heart transplant
CMV CMI

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases