Determining a Viral Load Threshold for Treating Cytomegalovirus (CMV)

PHASE4CompletedINTERVENTIONAL
Enrollment

165

Participants

Timeline

Start Date

February 28, 2003

Primary Completion Date

December 31, 2011

Study Completion Date

February 28, 2013

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"

Trial Locations (1)

NW3 2QG

Royal Free London NHS Foundation Trust, Royal Free Hospital, Pond Street, London

All Listed Sponsors
lead

University College, London

OTHER

NCT00947141 - Determining a Viral Load Threshold for Treating Cytomegalovirus (CMV) | Biotech Hunter | Biotech Hunter