Valganciclovir for Treatment of Cytomegalovirus Infection in Solid Organ Transplant Patients

Cytomegalovirus Infection Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00730769
• Other study ID #: VALGAN-03
• Status: Completed
• Phase: Phase 4
• First received: August 5, 2008
• Last updated: September 19, 2011
• Start date: March 2004
• Est. completion date: July 2008

Study information

• Verified date: September 2011
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 2008
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Cytomegalovirus Infection
• Cytomegalovirus Infections
• Infection

Intervention

Drug:
• Single 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)

Locations

Country	Name	City	State
Spain	Hospital Universitari Bellvitge- Transplant Departments (Liver, Heart and Kidney)	L'Hospitalet de Llobregat	Barcelone

Sponsors (2)

Lead Sponsor	Collaborator
Salvador Gil-Vernet	Roche Pharma AG

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	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)	No