Contact information
Type
Scientific
Primary contact
Prof Paul D Griffiths
ORCID ID
Contact details
Department of Virology
The Royal Free & University Medical School
Pond Street
Hampstead
London
NW3 2QG
United Kingdom
+44 (0)20 7830 2997 ext 4951
p.griffiths@medsch.ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0256119271
Study information
Scientific title
Determining a viral load threshold for pre-emptive therapy for cytomegalovirus infection in transplant patients using real time PCR monitoring
Acronym
Study hypothesis
The aim of this study is to determine if quantitative measures of CMV viraemia can be applied to improve the treatment of CMV infection, and to evaluate the threshold of CMV viral load for initiation or discontinuation of pre-emptive therapy.
Ethics approval
Research Ethics Committee (REC), 20/11/2002, ref: 6077, re-approved on the 16th November following an MHRA audit
Study design
Open-label randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cytomegalovirus (CMV) infection
Intervention
Group A: 72 patients with low level CMV reactivation
Group B: 106 patients receiving pre-emptive therapy
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Current information as of 29/07/2009:
1. The number of patients in Group A with a low level of CMV reactivation who subsequently develop a viral load greater than 3000 copies/ml.
2, The number of patients in Group B who develop a second episode of a viral load above 3000 copies/ml after therapy has been discontinued at the defined viral load cut-offs.
Initial information at time of registration:
Number of patients receiving another course of therapy because viral load increases above 3000 copies/ml.
Secondary outcome measures
Current information as of 29/07/2009:
1. The duration of antiviral therapy needed to treat CMV viraemia
2. The rate of increase in viral load prior to starting pre-emptive therapy
3. Correlation of viral loads with CMV-specific immune function
Overall trial start date
05/12/2002
Overall trial end date
01/04/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
178 patients in total: stem cell, renal and liver transplant recipients with CMV reactivation
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
178
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
05/12/2002
Recruitment end date
01/04/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Virology
London
NW3 2QG
United Kingdom
Sponsor information
Funders
Funder type
Hospital/treatment centre
Funder name
The Royal Free Hampstead NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2016 results in https://www.ncbi.nlm.nih.gov/pubmed/27684379