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

Clinical and Virologic Response to HHV-8 Associated Multicentric Castleman's Disease to Valganciclovir

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.

Study Overview

• Status: Withdrawn
• Conditions: Giant Lymph Node Hyperplasia
• Intervention / Treatment: Drug: Valganciclovir

Detailed Description

All participants will undergo an initial screening appointment. At this visit, participants will be tested for Human Herpesvirus 8 (HHV-8), the virus that is associated with MCD, and we will review participants' medical history and medical records to determine whether he/she has MCD. If participants do not live within the Seattle area, this visit may occur over the phone.

Those who qualify for the study will be followed for up to 2 years. During that 2 year period, participants will be asked to collect oral swabs once a week and have blood drawn monthly. If subjects do not live within the Seattle-area, they will be asked to ship these samples to UW for testing. We will provide subjects with instructions for these shipments. This will be done at no cost to the participant.

If during the 2 year period the participant experiences a MCD flare, he/she will be admitted to the University of Washington Medical Center's Clinic Research Center for 14-days. If the participant does not live within the Seattle-area, all travel expenses will be covered.

The study will enroll a total of 8 patients who will receive open-label valganciclovir for 14-days. Everyday during the hospitalization, participants will have blood drawn (to check your HHV-8 levels), 1 oral swab will be collected and a general physical exam will be performed.

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Valganciclovir; valganciclovir open label, two 450mg tablets orally, twice a day; Other Names: Valcyte

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to improvement	14 days
One-log reduction in HHV-8 peripheral blood viral load	14 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Hoffmann-La Roche
• Investigators: Principal Investigator: Corey Casper, MD, MPH, University of Washington

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Anticipated): May 1, 2009

Study Registration Dates

• First Submitted: August 8, 2006
• First Submitted That Met QC Criteria: August 8, 2006
• First Posted (Estimate): August 9, 2006

Study Record Updates

• Last Update Posted (Actual): April 18, 2017
• Last Update Submitted That Met QC Criteria: April 14, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Hyperplasia; Castleman Disease; Lymphadenopathy; Anti-Infective Agents; Antiviral Agents; Valganciclovir
• Other Study ID Numbers: 30618; VAL096