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

The Clinical Utility of Monitoring for Human Herpesvirus-6 (HHV-6) and Human Herpesvirus-7 (HHV-7) After Liver Transplant: A Randomized Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00242099
Enrollment
160
Registered
2005-10-19
Start date
2005-02-28
Completion date
2007-11-30
Last updated
2008-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transplant

Keywords

liver transplant, HHV-6, HHV-7, Human Herpesvirus-6, Human Herpesvirus-7

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.

Interventions

PROCEDUREMonitoring - blood samples drawn to test for HHV-6 and HHV-7

Sponsors

The Physicians' Services Incorporated Foundation
CollaboratorOTHER
University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Adverse clinic events due to direct or indirect effects.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026