Valganciclovir for Treatment of Cytomegalovirus Infection in Solid Organ Transplant Patients

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Salvador Gil-Vernet
• Collaborator: Roche Pharma AG
• Treatments: Ganciclovir; Ganciclovir triphosphate; Valganciclovir

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)