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Determining a Viral Load Threshold for Treating Cytomegalovirus (CMV)

NCT00947141 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2017-10-27

No results posted yet for this study

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.

Conditions

  • Viraemia

Interventions

DRUG

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

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

OTHER

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

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

DRUG

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

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

OTHER

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

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

Sponsors & Collaborators

  • University College, London

    lead OTHER

Principal Investigators

  • Professor Paul D Griffiths, MD DSc · University College, London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-28
Primary Completion
2011-12-31
Completion
2013-02-28

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00947141 on ClinicalTrials.gov