Cytomegalovirus (CMV) infection Infections and Infestations Cytomegalovirus (CMV) infection
Conditions
Interventions
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. D
Sponsors
University Hospital Complex of Vaud (Centre Hospitalier Universitaire Vaudois [CHUV]) (Switzerland)
Eligibility
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Failure to give written informed consent 2. Known intolerance to ganciclovir or valganciclovir
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Switzerland
Outcome results
None listed