VICTOR Study - A Study of Valcyte (Valganciclovir po) Compared to Ganciclovir iv in Patients With Cytomegalovirus (CMV) Disease Who Are Solid Organ Transplant Recipients

Conditions

Cytomegalovirus Infections

Brief summary

This 2 arm study will evaluate the efficacy and safety of oral Valcyte compared with intravenous ganciclovir for the treatment of CMV disease in solid organ transplant recipients. Eligible patients will be randomized to receive either 1)Valcyte 900mg po bid or 2)ganciclovir 5mg/kg iv bid. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Genovefa A. Papanicolaou, Fernanda P. Silveira, Amelia Langston, Marcus R. Pereira, Robin K. Avery et al. (11 authors)

Clinical Infectious Diseases2018-10-03212 citations

10.1093/cid/ciy706

Characterization of cytomegalovirus disease in solid organ transplant recipients by markers of inflammation in plasma.

Rollag H, Ueland T, Asberg A, Hartmann A, Jardine AG, Humar A, Pescovitz MD, Bignamini AA, Aukrust P.

2013-04-089 citations

10.1371/journal.pone.0060767

Virologic suppression measured by a cytomegalovirus (CMV) DNA test calibrated to the World Health Organization international standard is predictive of CMV disease resolution in transplant recipients.

Razonable RR, Åsberg A, Rollag H, Duncan J, Boisvert D, Yao JD, Caliendo AM, Humar A, Do TD.

2013-02-1555 citations

10.1093/cid/cit096

Interventions

DRUGGanciclovir

5mg/kg iv bid for 21 days

DRUGvalganciclovir [Valcyte]

900mg po bid for 21 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* adult patients \>=18 years of age; * recipients of solid organ(s) transplant; * virologic and clinical evidence of CMV disease after transplantation; * patients of childbearing potential must be prepared to use effective contraception throughout, and for 90 days after the end of the study.

Exclusion criteria

* life-threatening CMV disease according to the investigator's judgment; * pregnant or lactating women.

Design outcomes

Primary

Measure	Time frame
Incidence of treatment success (CMV viremia BLQ)	Day 21

Secondary

Measure	Time frame
Time to eradication of CMV viremia, percentage of patients with resolution of symptoms, percentage of patients with eradication of CMV viremia, time to CMV viremia recurrence, effect on HHV-6, HHV-7 and EBV viremia.	Throughout study
AEs, laboratory parameters, appearance of ganciclovir resistance.	Throughout study

Countries

Australia, Austria, Belgium, Brazil, Canada, Croatia, Estonia, India, Ireland, Italy, Latvia, Mexico, New Zealand, Norway, Poland, Serbia, Spain, Switzerland, Turkey (Türkiye), United Kingdom, Venezuela

Outcome results

None listed