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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00361933
Recruitment Status : Withdrawn (Research never begun.)
First Posted : August 9, 2006
Last Update Posted : April 18, 2017
Hoffmann-La Roche
Information provided by (Responsible Party):
Corey Casper, University of Washington

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.

Condition or disease Intervention/treatment Phase
Giant Lymph Node Hyperplasia Drug: Valganciclovir Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical and Virologic Response to HHV-8 Associated Multicentric Castleman's Disease to Valganciclovir
Study Start Date : December 2008
Actual Primary Completion Date : May 2009
Estimated Study Completion Date : May 2009

Arm Intervention/treatment
Experimental: 1 Drug: Valganciclovir
valganciclovir open label, two 450mg tablets orally, twice a day
Other Name: Valcyte

Primary Outcome Measures :
  1. Time to improvement [ Time Frame: 14 days ]
  2. One-log reduction in HHV-8 peripheral blood viral load [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Safety and tolerability of valganciclovir [ Time Frame: 14 days ]
  2. Proportion of patients resolving symptoms by 4 days [ Time Frame: 14 days ]
  3. HHV-8 detection in the plasma or oropharynx [ Time Frame: 14 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00361933

Sponsors and Collaborators
University of Washington
Hoffmann-La Roche
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Principal Investigator: Corey Casper, MD, MPH University of Washington
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Responsible Party: Corey Casper, Professor, University of Washington Identifier: NCT00361933    
Other Study ID Numbers: 30618
First Posted: August 9, 2006    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Castleman Disease
Pathologic Processes
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antiviral Agents
Anti-Infective Agents