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

Sponsor:	University of Washington
Collaborator:	Hoffmann-La Roche
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00361933

Purpose

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.

Condition	Intervention	Phase
Giant Lymph Node Hyperplasia	Drug: Valganciclovir	Phase IV

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Clinical and Virologic Response to HHV-8 Associated Multicentric Castleman's Disease to Valganciclovir

Resource links provided by NLM:

MedlinePlus related topics: Kaposi's Sarcoma

Drug Information available for: Valganciclovir hydrochloride Valganciclovir

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:

Time to improvement [ Time Frame: 14 days ] [ Designated as safety issue: No ]
One-log reduction in HHV-8 peripheral blood viral load [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability of valganciclovir [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Proportion of patients resolving symptoms by 4 days [ Time Frame: 14 days ] [ Designated as safety issue: No ]
HHV-8 detection in the plasma or oropharynx [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	8
Study Start Date:	December 2008
Estimated Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Valganciclovir valganciclovir open label, two 450mg tablets orally, twice a day

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00361933

Sponsors and Collaborators

University of Washington

Hoffmann-La Roche

Investigators

Principal Investigator:

Corey Casper, MD, MPH

University of Washington

More Information

No publications provided

Responsible Party:	University of Washington ( Corey Casper, MD, MPH )
ClinicalTrials.gov Identifier:	NCT00361933 History of Changes
Other Study ID Numbers:	30618-A, VAL096
Study First Received:	August 8, 2006
Last Updated:	June 16, 2009
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Additional relevant MeSH terms:

Giant Lymph Node Hyperplasia
Hyperplasia
Lymphatic Diseases
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes

Valganciclovir
Ganciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 01, 2010