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

This study has been withdrawn prior to enrollment.
(Research never begun.)
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00361933
First received: August 8, 2006
Last updated: June 16, 2009
Last verified: June 2009
  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 4

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:


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

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
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, see Learn About Clinical Studies.

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: Corey Casper, MD, MPH, University of Washington
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
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Valganciclovir
Ganciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014