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Completed

NCT Number: NCT00431353

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

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.

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Key information

Conditions

Cytomegalovirus Infections DNA Virus Infections Herpesviridae Infections Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chermside, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ganciclovir

Drug

5mg/kg iv bid for 21 days

valganciclovir [Valcyte]

Drug

900mg po bid for 21 days

Primary outcomes

  1. Incidence of treatment success (CMV viremia BLQ)

    Time frame: Day 21

Secondary outcomes

  1. 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

  2. AEs, laboratory parameters, appearance of ganciclovir resistance.

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Open-label Study of the Effect of Oral Valcyte Versus Intravenous Ganciclovir on CMV Viremia in Solid Organ Transplant Patients

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Feb 5, 2007
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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