Valganciclovir to Treat HHV-8 Associated Multicentric Castleman's Disease

• Status: Withdrawn
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to learn whether people who are experiencing an MCD (multicentric Castleman's Disease) flare will improve after taking valganciclovir. MCD is a type of inflammatory disease associated with Human Herpesvirus 8 (HHV-8). Valganciclovir is FDA approved for treating a different type of Human Herpesvirus, but not approved for the treatment of HHV-8. It is therefore considered experimental in this study.

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

Details

• Lead Sponsor: University of Washington
• Collaborator: Hoffmann-La Roche
• Treatments: Ganciclovir; Valganciclovir

Criteria

Inclusion Criteria:

• Age 18 years

• Negative pregnancy test (for female participants)

• Diagnosis of MCD for over one year, with a history of at least one MCD recurrence annually

• Evidence of infection with HHV-8

• A willingness to travel and reside temporarily in Seattle for completion of the study protocol.

• For HIV-infected participants, a stable antiretroviral regimen for the past 6 months

Exclusion Criteria:

• Concurrent Kaposi sarcoma or non-hodgkin's lymphoma

• A history or evidence of CMV disease

• Hypersensitivity to ganciclovir or valganciclovir

• Use of high-dose acyclovir (>800 mg bid), valacyclovir (>1000 mg qd) or famciclovir (>1000 mg qd), ganciclovir, foscarnet, or cidofovir

• Neutropenia (ANC <1500)

• Renal insufficiency with serum creatinine > 1.5 mg/ml or CrCl < 60

• AST or ALT > 5 times upper limit of normal

• Concurrent administration of medications which are often associated with severe neutropenia or thrombocytopenia (i.e., chemotherapy, etc)

• Concurrent administration of probenecid or didanosine.

• Inability to read and understand English