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Clinical Utility of Monitoring for Human Herpesvirus-6 (HHV-6) and Human Herpesvirus-7 (HHV-7) After Liver Transplant

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ClinicalTrials.gov Identifier: NCT00242099
Recruitment Status : Completed
First Posted : October 19, 2005
Last Update Posted : April 16, 2008
Information provided by:

Study Description
Brief Summary:
Human herpesvirus-6 (HHV-6) and -7 (HHV-7) infections are common after transplantation. Such infections may predispose transplant patients to other infections, contribute to a recurrence of hepatitis C virus, and affect rejection and function of the transplanted liver. Given the significant clinical impact of these viruses, routine laboratory monitoring may be beneficial by identifying patients who have persistent or high levels of infection. In these patients, immunosuppressive medications could be adjusted, or antiviral medications administered. There are currently no randomized trials that address this important question. This prospective, randomized trial will analyze whether routine laboratory monitoring for HHV-6 and -7 is clinically useful, and whether it would improve overall outcomes in transplant recipients.

Condition or disease Intervention/treatment Phase
Transplant Procedure: Monitoring - blood samples drawn to test for HHV-6 and HHV-7 Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Clinical Utility of Monitoring for Human Herpesvirus-6 (HHV-6) and Human Herpesvirus-7 (HHV-7) After Liver Transplant: A Randomized Trial
Study Start Date : February 2005
Primary Completion Date : November 2007
Study Completion Date : November 2007
Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Adverse clinic events due to direct or indirect effects.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

    • Recipients of a liver transplant
    • Able to give written informed consent
    • Are willing and able to comply with the protocol
    • Age >= 18 years

Exclusion Criteria:

The following patients are not eligible for inclusion in the study:

  • Patients unwilling or unable to give informed consent
Contacts and Locations

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): NCT00242099

Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G2N2
Sponsors and Collaborators
University Health Network, Toronto
The Physicians' Services Incorporated Foundation
Principal Investigator: Atul Humar, MD University Health Network, Toronto
Principal Investigator: Deepali Kumar, MD University Health Network, Toronto
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00242099     History of Changes
Other Study ID Numbers: 04-0760-AE
First Posted: October 19, 2005    Key Record Dates
Last Update Posted: April 16, 2008
Last Verified: February 2005

Keywords provided by University Health Network, Toronto:
liver transplant
Human Herpesvirus-6
Human Herpesvirus-7