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Valganciclovir for Treatment of Cytomegalovirus Infection in Solid Organ Transplant Patients

Information source: Hospital Universitari de Bellvitge
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cytomegalovirus Infection

Intervention: Single arm (ganciclovir and valganciclovir) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Salvador Gil-Vernet

Official(s) and/or principal investigator(s):
Salvador - Gil-Vernet, Medicine, Study Chair, Affiliation: Nephrology Department. Hospital Universitari of Bellvitge


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.

Clinical Details

Official title: Phase IV.II Pilot Study of Treatment of Cytomegalovirus Infection With a Brief Induction With Ganciclovir i.v. Followed by Valganciclovir Oral in Solid Organ Transplant Patients.

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Dissapeareance of CMV (pp65) antigenemia, determined in peripheral blood mononuclear cells (PBMC).

Secondary outcome:

Dissapareance of Cytomegalovirus viremia measured by PCR, determined in plasma samples.

Area under the curve (AUC) of Ganciclovir after ganciclovir i.v. and valganciclovir oral in steady state.

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


Locations and Contacts

Hospital Universitari Bellvitge- Transplant Departments (Liver, Heart and Kidney), L'Hospitalet de Llobregat, Barcelone 08907, Spain
Additional Information

Starting date: March 2004
Last updated: September 19, 2011

Page last updated: August 23, 2015

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