NCT02370758

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 25, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2017

Completed
Last Updated

September 21, 2017

Status Verified

September 1, 2017

Enrollment Period

1.8 years

First QC Date

February 18, 2015

Last Update Submit

September 20, 2017

Conditions

Cytomegalovirus Viraemia

Keywords

Quantiferon-CMVQuantiferon-MonitorSolid Organ TransplantsCMV Disease

Outcome Measures

Primary Outcomes (1)

  • Virologic recurrence or disease recurrence

    6 months

Study Arms (2)

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.

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.

Interventions

Valganciclovir or GanciclovirDRUG
Low CMV CMI

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Known ganciclovir-resistant CMV
  • Known intolerance to valganciclovir or ganciclovir
  • Unable to comply with protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Toronto, Ontario, M5G2N2, Canada

Location

MeSH Terms

Interventions

ValganciclovirGanciclovir

Intervention Hierarchy (Ancestors)

AcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Atul Humar, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

  • Deepali Kumar, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2015

First Posted

February 25, 2015

Study Start

November 1, 2014

Primary Completion

September 1, 2016

Study Completion

June 16, 2017

Last Updated

September 21, 2017

Record last verified: 2017-09

Locations

CA(1)