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

Hoffmann-La Roche325 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

325

Conditions

Cytomegalovirus Infections

Interventions

GanciclovirDRUG

5mg/kg iv bid for 21 days

valganciclovir [Valcyte]DRUG

900mg po bid for 21 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (50)

Outcomes

Primary Outcomes

Incidence of treatment success (CMV viremia BLQ)

Time frame: Day 21

Secondary Outcomes

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.

Time frame: Throughout study

AEs, laboratory parameters, appearance of ganciclovir resistance.

Time frame: Throughout study

Data from ClinicalTrials.gov

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Unnamed facility

Chermside, Australia

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Darlinghurst, Australia

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Sydney, Australia

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Woolloongabba, Australia

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Vienna, Austria

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Brussels, Belgium

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Campinas, Brazil

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Porto Alegre, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

...and 40 more locations