Condition category
Infections and Infestations
Date applied
11/12/2006
Date assigned
14/02/2007
Last edited
04/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Nancy Perrottet

ORCID ID

Contact details

Division de Pharmacologie et Toxicologie Cliniques
Hôpital de Beaumont - 06.605
Lausanne
1011
Switzerland
Nancy.Perrottet@chuv.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Valganciclovir is a prodrug of ganciclovir with improved oral bioavailability, potentially useful for the treatment of Cytomegalovirus (CMV) infection in organ transplant recipients and for the prophylaxis of CMV infection in liver and lung transplant patients, two indications currently not validated. Our hypothesis is that valganciclovir produces drug levels and virological responses similar to those obtained with intravenous ganciclovir. This would provide indirect evidence for the use of oral valganciclovir instead of intravenous ganciclovir within the settings mentioned above.

Ethics approval

Approval received by the local ethics committee (Commission d’éthique de la recherche clinique, Faculté de Médecine et Biologie, Université de Lausanne) on the 20th September 2005 (ref: 94/05).

Study design

Prospective observational trial with historical controls

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cytomegalovirus (CMV) infection

Intervention

Patients will receive valganciclovir (900 mg once daily [QD], adjusted to their renal function according to the information provided by the manufacturer), over three months, for primary prophylaxis. During such period, blood samples will be collected monthly to determine ganciclovir plasma levels (immediately before and three hours after oral administration) and CMV blood viral loads will be measured by real time quantitative Polymerase Chain Reaction (PCR). Upon the initial prophylaxis termination, and over the following three months, universal blood monitoring for CMV infection will continue on a fortnightly basis.

In case of detection of high viremia level (more than 10,000 - 100,000 copies of CMV Deoxyribonucleic Acid [DNA]/million leukocytes) and/or symptomatic CMV disease, patients will receive therapeutic dosages of valganciclovir (900 mg twice daily [bid], adjusted to renal function) until they achieve a clinical response or their viral load drops. Throughout such treatment phase, ganciclovir plasma level and CMV viral load assays will be performed weekly. Treated subjects will then receive “secondary prophylaxis” (half the therapeutic dose of valganciclovir, 900 mg QD, adjusted to renal function) for one month, with fortnightly ganciclovir plasma levels and CMV viral load assays. In selected patients, treating physicians may opt at their discretion for intravenous ganciclovir rather than oral valganciclovir, based on their clinical judgement. Any such patients will have plasma levels and CMV viral load tested weekly.

Intervention type

Drug

Phase

Not Specified

Drug names

Valganciclovir

Primary outcome measures

1. To determine whether the average ganciclovir blood levels following the oral administration of valganciclovir are comparable to the known therapeutic range associated with the use of intravenous ganciclovir
2. To assess the variability of ganciclovir blood levels attained with oral valganciclovir, to evaluate its potential repercussions on therapeutic response, and to identify influential factors which modulate valganciclovir absorption and disposition

Secondary outcome measures

1. To evaluate the relationship between ganciclovir blood levels and anti-CMV efficacy using a pharmacokinetic-pharmacodynamic model incorporating the relevant pharmacokinetic, virological and clinical response parameters
2. To determine the impact of specific clinical conditions (malabsorption, cystic fibrosis, kidney failure), concomitant medications (drugs inhibiting organic anion transport) and possibly genetic traits (drug transporters polymorphisms) on ganciclovir and valganciclovir pharmacokinetics and dose requirements
3. To further assess the safety and tolerability of oral valganciclovir

Overall trial start date

15/11/2005

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Solid organ transplant recipient
2. More than or equal to 18 years old
3. At risk for CMV disease (D+/R-, D+/R+ or D-/R+)
4. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

100

Participant exclusion criteria

1. Failure to give written informed consent
2. Known intolerance to ganciclovir or valganciclovir

Recruitment start date

15/11/2005

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Switzerland

Trial participating centre

Division de Pharmacologie et Toxicologie Cliniques
Lausanne
1011
Switzerland

Sponsor information

Organisation

University Hospital Complex of Vaud (Centre Hospitalier Universitaire Vaudois [CHUV]) (Switzerland)

Sponsor details

Rue du Bugnon 46
Lausanne
1011
Switzerland
+ 41 (0)21 314 11 11
info@chuv.ch

Sponsor type

Hospital/treatment centre

Website

http://www.chuv.ch/

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital Complex of Vaud (Centre Hospitalier Universitaire Vaudois [CHUV]) (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Roche (Switzerland) - unrestricted grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes