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

NCT00361933 | Withdrawn Phase 4 DMC

• 2 other identifiers: 30618VAL096
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Giant Lymph Node Hyperplasia

Outcome Measures

Primary Outcomes (2)

• Time to improvement

  14 days

• One-log reduction in HHV-8 peripheral blood viral load

  14 days

Secondary Outcomes (3)

• Safety and tolerability of valganciclovir

  14 days

• Proportion of patients resolving symptoms by 4 days

  14 days

• HHV-8 detection in the plasma or oropharynx

  14 days

Study Arms (1)

1

EXPERIMENTAL

Drug: Valganciclovir

Interventions

Valganciclovir DRUG

valganciclovir open label, two 450mg tablets orally, twice a day

Also known as: Valcyte

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Hoffmann-La Roche: collaborator

MeSH Terms

Conditions

Castleman Disease

Interventions

Valganciclovir

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ganciclovir; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Corey Casper, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 8, 2006
• First Posted: August 9, 2006
• Study Start: December 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: April 18, 2017

Record last verified: 2017-04