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