VICTOR Study - A Study of Valcyte (Valganciclovir po) Compared to Ganciclovir iv in Patients With Cytomegalovirus (CMV) Disease Who Are Solid Organ Transplant Recipients
NCT ID: NCT00431353
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
325 participants
INTERVENTIONAL
2004-04-30
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
valganciclovir [Valcyte]
900mg po bid for 21 days
2
Ganciclovir
5mg/kg iv bid for 21 days
Interventions
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Ganciclovir
5mg/kg iv bid for 21 days
valganciclovir [Valcyte]
900mg po bid for 21 days
Eligibility Criteria
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Inclusion Criteria
* 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
* pregnant or lactating women.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Chermside, , Australia
Darlinghurst, , Australia
Sydney, , Australia
Woolloongabba, , Australia
Vienna, , Austria
Brussels, , Belgium
Campinas, , Brazil
Porto Alegre, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Edmonton, Alberta, Canada
Toronto, Ontario, Canada
Zagreb, , Croatia
Tallinn, , Estonia
Tartu, , Estonia
Chennai, , India
Lucknow, , India
New Delhi, , India
Vellore, , India
Dublin, , Ireland
Coppito, , Italy
Padua, , Italy
Riga, , Latvia
Aguascalientes, , Mexico
Mexico City, , Mexico
Auckland, , New Zealand
Oslo, , Norway
Bydgoszcz, , Poland
Gdansk, , Poland
Poznan, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Zabrze, , Poland
Belgrade, , Serbia
Alicante, , Spain
Barakaldo, , Spain
Barcelona, , Spain
Madrid, , Spain
San Cristóbal de La Laguna, , Spain
Basel, , Switzerland
Antalya, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Liverpool, , United Kingdom
Oxford, , United Kingdom
Caracas, , Venezuela
Maracaibo, , Venezuela
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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MV17973
Identifier Type: -
Identifier Source: org_study_id