CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 165 enrolled
Drug / intervention
ganciclovir (start when CMV PCR >200copies / ml x2) +3 moredrug
Likely dose
ganciclovir (start when CMV PCR >200copies / ml x2) 900mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00947141
NCT00947141Phase 4Completed
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Determining a Viral Load Threshold for Pre-emptive Therapy for Cytomegalovirus Infection in Transplant Patients Using Real Time Polymerase Chain Reaction (PCR) Monitoring

University College, London·interventional·Posted Jul 27, 2009·Updated Oct 27, 2017

In Brief

A Phase 4 clinical trial evaluating ganciclovir (start when CMV PCR >200copies / ml x2), Monitor (Treatment starts when CMV PCR >3,000 copies / ml), and 2 other interventions for Viraemia. Completed, enrolled 165 participants across 1 site.

Detailed 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 valganciclovir, ganciclovir and/or foscarnet; b) whether those patients with 'high level' viral load results (above 3,000 copies/ml) could stop preemptive therapy earlier, thus maximising the benefits of therapy and minimising its risks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsViraemia
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 27, 2009
Enrollment StartFeb 1, 2003
Primary CompletionDec 1, 2011
Study CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 16.9 years ago

Interventions

ganciclovir (start when CMV PCR >200copies / ml x2)drug

Group A: Start ganciclovir when CMV PCR \>200copies / ml x 2) . Participants are randomised to either Monitor or Treat. If monitored, treatment will only begin if viral load has increased \> 3,000. If treated (and monitored) treat until \<200 copies on 2 consecutive occasions. Routine standard of care would include treatment of Valganciclovir 900mg Tablet BD (dose adjusted for renal impairment), Ganciclovir 5mg/kg BD IV, or Foscarnet 60mg/kg according to randomisation within Group A or Group B

Monitor (Treatment starts when CMV PCR >3,000 copies / ml)other

Group A: CMV viral load between 200-3,000 copies/ml (on 2 occasions). Participants are randomised to either Monitor or Treat. If monitored, treatment will only begin if viral load has increased \> 3,000. If treated (and monitored) treat until \<200 copies on 2 consecutive occasions. Routine standard of care would include treatment of Valganciclovir 900mg Tablet BD (dose adjusted for renal impairment), Ganciclovir 5mg/kg BD IV, or Foscarnet 60mg/kg according to randomisation within Group A or Group B

Stop treatment when 2 levels CMV PCR <3,000 copies / mldrug

Group B: Viral load \> 3,000 copies/ml. Participants are randomised to treat until \< 3,000 copies/ml on 2 occasions or treat until \<200 copies/ml on 2 consecutive occasions. Routine standard of care would include treatment of Valganciclovir 900mg Tablet BD (dose adjusted for renal impairment), Ganciclovir 5mg/kg BD IV, or Foscarnet 60mg/kg according to randomisation within Group A or Group B

Monitor (Treatment stops CMV PCR <200 copies / ml x2)other

Group B: Viral load \> 3,000 copies/ml. Participants are randomised to treat until \< 3,000 copies/ml on 2 occasions or treat until \<200 copies/ml on 2 consecutive occasions. Routine standard of care would include treatment of Valganciclovir 900mg Tablet BD (dose adjusted for renal impairment), Ganciclovir 5mg/kg BD IV, or Foscarnet 60mg/kg according to randomisation within Group A or Group B