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

NCT00431353 | Completed Phase 4

• 1 other identifier: MV17973
• Study Type: interventional
• Target: 325
• Locations: 19 countries
• Sites: 47

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.

Conditions

Cytomegalovirus Infections

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment success (CMV viremia BLQ)

  Day 21

Secondary Outcomes (2)

• 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

Study Arms (2)

1

EXPERIMENTAL

Drug: valganciclovir [Valcyte]

2

EXPERIMENTAL

Drug: Ganciclovir

Interventions

Ganciclovir DRUG

5mg/kg iv bid for 21 days

2

valganciclovir [Valcyte] DRUG

900mg po bid for 21 days

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (50)

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Chermside, 4032, Australia

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Darlinghurst, 2010, Australia

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Sydney, 2145, Australia

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Woolloongabba, 4102, Australia

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Vienna, 1090, Austria

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Brussels, 1070, Belgium

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Campinas, 13086-970, Brazil

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Porto Alegre, 90020-090, Brazil

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São Paulo, 01323-900, Brazil

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São Paulo, 04038-002, Brazil

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São Paulo, 05403-900, Brazil

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São Paulo, 05651-901, Brazil

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Edmonton, Alberta, T6G 2B7, Canada

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Toronto, Ontario, M5G 1L7, Canada

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Zagreb, 10000, Croatia

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Tallinn, 10617, Estonia

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Tartu, 51014, Estonia

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Chennai, 600 004, India

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Lucknow, 226 014, India

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New Delhi, 110076, India

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Vellore, 632 004, India

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Dublin, 4, Ireland

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Coppito, 67100, Italy

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Padua, 35128, Italy

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Riga, LV-1002, Latvia

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Aguascalientes, 20230, Mexico

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Mexico City, 06720, Mexico

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Auckland, 1001, New Zealand

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Oslo, Norway

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Bydgoszcz, 85-094, Poland

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Gdansk, 80-211, Poland

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Poznan, 60-479, Poland

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Warsaw, 02-006, Poland

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Wroclaw, 50-417, Poland

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Zabrze, 41-800, Poland

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Belgrade, 11000, Serbia

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Alicante, 03010, Spain

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Barakaldo, 48903, Spain

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Barcelona, 08907, Spain

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Madrid, Spain

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San Cristóbal de La Laguna, Spain

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Basel, 4031, Switzerland

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Antalya, 07000, Turkey (Türkiye)

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Istanbul, 34126, Turkey (Türkiye)

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Istanbul, 34662, Turkey (Türkiye)

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Izmir, 35100, Turkey (Türkiye)

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Liverpool, L7 8XP, United Kingdom

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Oxford, OX3 7LJ, United Kingdom

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Caracas, 1040, Venezuela

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Maracaibo, 4001, Venezuela

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Related Publications (6)

• Vernooij RW, Michael M, Colombijn JM, Owers DS, Webster AC, Strippoli GF, Hodson EM. Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2025 Jan 14;1(1):CD005133. doi: 10.1002/14651858.CD005133.pub4.

  PMID: 39807668 DERIVED

• Vernooij RW, Michael M, Ladhani M, Webster AC, Strippoli GF, Craig JC, Hodson EM. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2024 May 3;5(5):CD003774. doi: 10.1002/14651858.CD003774.pub5.

  PMID: 38700045 DERIVED

• Ueland T, Rollag H, Hartmann A, Jardine A, Humar A, Bignamini AA, Asberg A, Aukrust P. Increased osteoprotegerin predicts poor virological outcome during anticytomegalovirus therapy in solid organ transplant recipients. Transplantation. 2015 Jan;99(1):100-5. doi: 10.1097/TP.0000000000000227.

  PMID: 24983306 DERIVED

• Ueland T, Rollag H, Hartmann A, Jardine AG, Humar A, Michelsen AE, Bignamini AA, Asberg A, Aukrust P. Secreted Wnt antagonists during eradication of cytomegalovirus infection in solid organ transplant recipients. Am J Transplant. 2014 Jan;14(1):210-5. doi: 10.1111/ajt.12506. Epub 2013 Nov 13.

  PMID: 24224707 DERIVED

• Rollag H, Ueland T, Asberg A, Hartmann A, Jardine AG, Humar A, Pescovitz MD, Bignamini AA, Aukrust P. Characterization of cytomegalovirus disease in solid organ transplant recipients by markers of inflammation in plasma. PLoS One. 2013 Apr 8;8(4):e60767. doi: 10.1371/journal.pone.0060767. Print 2013.

  PMID: 23593305 DERIVED

• Razonable RR, Asberg A, Rollag H, Duncan J, Boisvert D, Yao JD, Caliendo AM, Humar A, Do TD. 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. Clin Infect Dis. 2013 Jun;56(11):1546-53. doi: 10.1093/cid/cit096. Epub 2013 Feb 15.

  PMID: 23418272 DERIVED

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Ganciclovir; Valganciclovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2007
• First Posted: February 5, 2007
• Study Start: April 1, 2004
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

TU (4); BR (6); SE (1); CH (1); NZ (1); AU (4); CR (1); GB (2); IT (2); IN (4); IE (1); ME (2); CA (2); LA (1); PL (6); ES (5); NO (1); BE (1); VE (2)