Cytomegalovirus InfectionsPhase 4NCT00431353
VICTOR Study - A Study of Valcyte (Valganciclovir po) Compared to Ganciclovir iv in Patients With Cytomegalovirus (CMV) Disease Who Are Solid Organ Transplant Recipients
A Phase 4 study testing Ganciclovir and valganciclovir [Valcyte] in people with Cytomegalovirus Infections, run by Hoffmann-La Roche at 50 sites in 21 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Infections
- What is being tested?
- Ganciclovir and valganciclovir [Valcyte]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 50 sitesin 21 countries
- Study dates
- Apr 2004to Aug 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- life-threatening CMV disease according to the investigator's judgment;
- pregnant or lactating women.
Trial locations and contacts
50 sites in 21 countries.
50 sites in 21 countries
Brazil6 sites
Study site
Campinas, 13086-970
Study site
Porto Alegre, 90020-090
Study site
São Paulo, 01323-900
Study site
São Paulo, 04038-002
Study site
São Paulo, 05403-900
Study site
São Paulo, 05651-901
Poland6 sites
Study site
Bydgoszcz, 85-094
Study site
Gdansk, 80-211
Study site
Poznan, 60-479
Study site
Warsaw, 02-006
Study site
Wroclaw, 50-417
Study site
Zabrze, 41-800
Spain5 sites
Study site
Alicante, 03010
Study site
Barakaldo, 48903
Study site
Barcelona, 08907
Study site
Madrid
Study site
San Cristóbal de La Laguna
Australia4 sites
Study site
Chermside, 4032
Study site
Darlinghurst, 2010
Study site
Sydney, 2145
Study site
Woolloongabba, 4102
India4 sites
Study site
Chennai, 600 004
Study site
Lucknow, 226 014
Study site
New Delhi, 110076
Study site
Vellore, 632 004
Turkey (Türkiye)4 sites
Study site
Antalya, 07000
Study site
Istanbul, 34126
Study site
Istanbul, 34662
Study site
Izmir, 35100
Canada2 sites
Study site
Edmonton, Alberta, T6G 2B7
Study site
Toronto, Ontario, M5G 1L7
United Kingdom2 sites
Study site
Liverpool, L7 8XP
Study site
Oxford, OX3 7LJ
About this study
Official title: A Randomized, Open-label Study of the Effect of Oral Valcyte Versus Intravenous Ganciclovir on CMV Viremia in Solid Organ Transplant Patients
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
- Being tested
- Ganciclovir, valganciclovir [Valcyte]
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GanciclovirDrug
5mg/kg iv bid for 21 days
valganciclovir [Valcyte]Drug
900mg po bid for 21 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: valganciclovir [Valcyte] |
| 2 | Experimental | Not described Receives: Drug: Ganciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment success (CMV viremia BLQ)
Measured: 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.
Measured: Throughout study
AEs, laboratory parameters, appearance of ganciclovir resistance.
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2007 (estimated)
- Study startApr 2004
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431353
- Sponsor's protocol ID
- MV17973
- Status last verified
- Nov 2016
- First submitted
- 2 Feb 2007
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
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.
PubMed 39807668Vernooij 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.
PubMed 38700045Ueland 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.
PubMed 24983306Ueland 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.
PubMed 24224707Rollag 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.
PubMed 23593305Razonable 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.
PubMed 23418272
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Study of the Effect of Oral Valcyte Versus Intravenous Ganciclovir on CMV Viremia in Solid Organ Transplant Patients
- ClinicalTrials.gov ID
- NCT00431353
- Acronym / sponsor ID
- MV17973
- Conditions
- Cytomegalovirus Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 5 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: valganciclovir [Valcyte] |
| 2 | Experimental | Drug: Ganciclovir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- life-threatening CMV disease according to the investigator's judgment;
- pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ganciclovir5mg/kg iv bid for 21 days | Drug | 2 |
| valganciclovir [Valcyte]900mg po bid for 21 days | Drug | 1 |
Primary outcome
Incidence of treatment success (CMV viremia BLQ)
Time frame: Day 21
2 secondary outcomes
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
AEs, laboratory parameters, appearance of ganciclovir resistance.
Time frame: Throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Derived from this study: PubMed 39807668Vernooij 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.
- Derived from this study: PubMed 38700045Vernooij 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.
- Derived from this study: PubMed 24983306Ueland 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.
- Derived from this study: PubMed 24224707Ueland 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.
- Derived from this study: PubMed 23593305Rollag 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.
- Derived from this study: PubMed 23418272Razonable 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.
Related trials for Cytomegalovirus Infections
RecruitingObservational study
A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea
Cytomegalovirus (CMV)
RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
RecruitingPhase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Viral Infection
RecruitingPhase 2
CMV CTLs in Neonates With CMV Infection
Congenital Cytomegaloviral (CMV) Disease
RecruitingPhase 2
CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
50 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ganciclovir and valganciclovir [Valcyte] in people with Cytomegalovirus Infections, run by Hoffmann-La Roche at 50 sites in 21 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Brazil, Poland, Spain, Australia, India and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment success (CMV viremia BLQ) (time frame: Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00431353, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.