Cytomegalovirus Infection
Conditions
Keywords
Valganciclovir, Ganciclovir, Pharmacokinetics, Solid organ transplantation, Transplant
Brief summary
The objectives of this study were: 1. To demonstrate the efficacy/safety of a short therapeutic strategy of treatment of CMV infection/disease in SOT patients (kidney, liver and heart recipients) based on 21 days of treatment. 2. To compare the exposure to ganciclovir, at steady state, after oral valganciclovir with respect to ganciclovir given intravenously (i.v.). 3. Evaluate the security of this treatment with valganciclovir.
Detailed description
SOT recipients (kidney, liver and heart transplant) presenting CMV infection or disease were eligible for inclusion if they were ≥18 years of age and presented a positive CMV antigenemia (pp65) defined as ≥ 20positive cells/105 peripherical blood mononuclear cells (PBMC). Patients excluded were those with severe CMV tissue invasive disease, unable to receive oral medication, absolute neutrophil counts less than 500/ mm3, platelets \<25000 platelets/mm3, Hemoglobin\< 80g/l or estimated glomerular filtration rate\< 10 mL/min (according to the Cockcroft-Gault formula). Patients received a short induction treatment with ganciclovir i.v (Cymevene®; F. Hoffmann-La Roche Ltd, Basel, Switzerland) at the dose of 5 mg/kg/12h, by a peripherical vein infusion of one hour, during 5 days followed by treatment with oral valganciclovir (Valcyte®; F. Hoffmann-La Roche Ltd, Basel, Switzerland) at 900 mg/12h during 16 days, after meals, until complete a total of 21 days of treatment. In patients with impaired renal function ganciclovir i.v. and oral valganciclovir doses were adjusted at each visit according to estimated Glomerular Filtration Rate (GFR) by Cockcroft-Gault equation, as recommended by the manufacturer.
Interventions
DRUGSingle arm (ganciclovir and valganciclovir)
Patients received a short induction of IV ganciclovir at 5 mg/kg bid for 5 days (1 hour infusion) , followed by treatment with oral valganciclovir at 900 mg bid (after meals) for 16 days up to complet 21 days of treatment. In patients with impaired renal function, IV ganciclovir and oral valganciclovir doses were adjusted at each visit according to estimated GFR (Cockroft-Gault equation)
Sponsors
Roche Pharma AG
Salvador Gil-Vernet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥18 years of age, solid organ transplant recipients. * presented a CMV infection demonstrated by CMV antigenemia (pp65) defined as ≥ 20positive cells/105 peripherical blood mononuclear cells (PBMC). * gave written informed consent.
Exclusion criteria
* HIV patients. * Multiorganic transplant. * Severe CMV tissue invasive disease. * Unable to receive oral medication. * absolute neutrophil counts less than 500/ mm3. * Platelets \<25000 platelets/mm3. * Hemoglobin\< 80g/l. * Estimated glomerular filtration rate\< 10 mL/min (according to the Cockcroft-Gault formula)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dissapeareance of CMV (pp65) antigenemia, determined in peripheral blood mononuclear cells (PBMC). | Baseline, day 5, 10, 15, 21 of treatment and day 30, 60 and 90 of follow-up. |
Secondary
| Measure | Time frame |
|---|---|
| Dissapareance of Cytomegalovirus viremia measured by PCR, determined in plasma samples. | Basal, day 5, 10, 15 and 21 of treatment and 30, 60 and 90 of treatment. |
| Area under the curve (AUC) of Ganciclovir after ganciclovir i.v. and valganciclovir oral in steady state. | Day 5 (ganciclovir i.v) and day 15 (valganciclovir oral) |
Countries
Spain
Outcome results
None listed