Clinical trial 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
Official title: A Randomized, Open-label Study of the Effect of Oral Valcyte Versus Intravenous Ganciclovir on CMV Viremia in Solid Organ Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cytomegalovirus Infections
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-02-05
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of treatment success (CMV viremia BLQ)
timeFrame: Day 21
Secondary outcomes:
measure: 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.
timeFrame: Throughout study
measure: AEs, laboratory parameters, appearance of ganciclovir resistance.
timeFrame: Throughout study
Other outcomes:
Locations:
city: Chermside
country: Australia
city: Darlinghurst
country: Australia
city: Sydney
country: Australia
city: Woolloongabba
country: Australia
city: Wien
country: Austria
city: Bruxelles
country: Belgium
city: Campinas
country: Brazil
city: Porto Alegre
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Edmonton
country: Canada
state: Alberta
city: Toronto
country: Canada
state: Ontario
city: Zagreb
country: Croatia
city: Tallinn
country: Estonia
city: Tartu
country: Estonia
city: Chennai
country: India
city: Lucknow
country: India
city: New Delhi
country: India
city: Vellore
country: India
city: Dublin
country: Ireland
city: Coppito
country: Italy
city: Padova
country: Italy
city: Riga
country: Latvia
city: Aguascalientes
country: Mexico
city: Mexico City
country: Mexico
city: Auckland
country: New Zealand
city: Oslo
country: Norway
city: Bydgoszcz
country: Poland
city: Gdansk
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Zabrze
country: Poland
city: Belgrade
country: Serbia
city: Alicante
country: Spain
city: Barakaldo
country: Spain
city: Barcelona
country: Spain
city: La Laguna
country: Spain
city: Madrid
country: Spain
city: Basel
country: Switzerland
city: Antalya
country: Turkey
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
city: Liverpool
country: United Kingdom
city: Oxford
country: United Kingdom
city: Caracas
country: Venezuela
city: Maracaibo
country: Venezuela
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.