Status:
COMPLETED
Determining a Viral Load Threshold for Treating Cytomegalovirus (CMV)
Lead Sponsor:
University College, London
Conditions:
Viraemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study aims to determine: a) whether those patients with 'low level' viral load results (between 200 and 3,000 copies/ml) could be monitored as opposed to starting preemptive therapy with valganci...
Detailed Description
Background and Study Rationale In transplant recipients with CMV infection, the risk of developing CMV disease is directly proportional to the CMV DNA viral load. Historically at The Royal Free, Hamp...
Eligibility Criteria
Inclusion
- All Stem Cell, Renal and Liver Transplant recipients.
- Willing to give informed consent.
- For Group A) All patients with CMV viraemia (between 200 and 3000 copies/ml) in the liver, renal and stem cell groups in two consecutive samples \& for Group B) Those patients requiring pre-emptive therapy because viral load is \> 3,000 copies/ml.
- All patients in either section of the study must be available for CMV PCR monitoring at least twice per week.
Exclusion
- Exclusion Criteria
- Profound neutropaenia considered to preclude administration of ganciclovir or profound renal failure considered to preclude administration of foscarnet.
- Inability to give informed consent.
- In the stem cell group, Donor negative, Recipient negative transplants.
- In the stem cell group: matched unrelated donors who are CMV seronegative.
- Those patients who have been in Group A cannot then enter the Group B part. of the study. 5.2.6 Those patients who have been in Group B cannot then enter the Group A part of the study.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00947141
Start Date
February 1 2003
End Date
February 1 2013
Last Update
October 27 2017
Active Locations (1)
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1
Royal Free London NHS Foundation Trust, Royal Free Hospital, Pond Street
London, United Kingdom, NW3 2QG