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

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00431353
• Collaborator: (none)
• Enrollment: 325
• Locations: 50
• Arms: 2
• Duration (Months): 52
• Patients Per Site: 6.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cytomegalovirus Infections	Drug: Ganciclovir; Drug: valganciclovir [Valcyte]	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 325 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Apr 1, 2004
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: valganciclovir [Valcyte]; 900mg po bid for 21 days
Experimental: 2	Drug: Ganciclovir; 5mg/kg iv bid for 21 days

Outcome Measures

Primary Outcome Measures

1. Incidence of treatment success (CMV viremia BLQ) [Day 21]

Secondary Outcome Measures

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. [Throughout study]

2. AEs, laboratory parameters, appearance of ganciclovir resistance. [Throughout study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Chermside		Australia	4032
2		Darlinghurst		Australia	2010
3		Sydney		Australia	2145
4		Woolloongabba		Australia	4102
5		Wien		Austria	1090
6		Bruxelles		Belgium	1070
7		Campinas		Brazil	13086-970
8		Porto Alegre		Brazil	90020-090
9		Sao Paulo		Brazil	01323-900
10		Sao Paulo		Brazil	04038-002
11		Sao Paulo		Brazil	05403-900
12		Sao Paulo		Brazil	05651-901
13		Edmonton	Alberta	Canada	T6G 2B7
14		Toronto	Ontario	Canada	M5G 1L7
15		Zagreb		Croatia	10000
16		Tallinn		Estonia	10617
17		Tartu		Estonia	51014
18		Chennai		India	600 004
19		Lucknow		India	226 014
20		New Delhi		India	110076
21		Vellore		India	632 004
22		Dublin		Ireland	4
23		Coppito		Italy	67100
24		Padova		Italy	35128
25		Riga		Latvia	LV-1002
26		Aguascalientes		Mexico	20230
27		Mexico City		Mexico	06720
28		Auckland		New Zealand	1001
29		Oslo		Norway
30		Bydgoszcz		Poland	85-094
31		Gdansk		Poland	80-211
32		Poznan		Poland	60-479
33		Warszawa		Poland	02-006
34		Wroclaw		Poland	50-417
35		Zabrze		Poland	41-800
36		Belgrade		Serbia	11000
37		Alicante		Spain	03010
38		Barakaldo		Spain	48903
39		Barcelona		Spain	08907
40		La Laguna		Spain
41		Madrid		Spain
42		Basel		Switzerland	4031
43		Antalya		Turkey	07000
44		Istanbul		Turkey	34126
45		Istanbul		Turkey	34662
46		Izmir		Turkey	35100
47		Liverpool		United Kingdom	L7 8XP
48		Oxford		United Kingdom	OX3 7LJ
49		Caracas		Venezuela	1040
50		Maracaibo		Venezuela	4001

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT00431353
• Other Study ID Numbers: MV17973
• First Posted: Feb 5, 2007
• Last Update Posted: Nov 2, 2016
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Cytomegalovirus Infections; Valganciclovir; Ganciclovir; Ganciclovir triphosphate

Study Results

No Results Posted as of Nov 2, 2016