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Trial record 1 of 3 for:    "Unicentric Castleman Disease" | "Valganciclovir"
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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.
ClinicalTrials.gov Identifier: NCT00361933
Recruitment Status : Withdrawn (Research never begun.)
First Posted : August 9, 2006
Last Update Posted : April 18, 2017
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Corey Casper, University of Washington

Tracking Information
First Submitted Date  ICMJE August 8, 2006
First Posted Date  ICMJE August 9, 2006
Last Update Posted Date April 18, 2017
Study Start Date  ICMJE December 2008
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2007)
  • Time to improvement [ Time Frame: 14 days ]
  • One-log reduction in HHV-8 peripheral blood viral load [ Time Frame: 14 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 8, 2006)
  • Time to improvement
  • One-log reduction in HHV-8 peripheral blood viral load
Change History Complete list of historical versions of study NCT00361933 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2007)
  • Safety and tolerability of valganciclovir [ Time Frame: 14 days ]
  • Proportion of patients resolving symptoms by 4 days [ Time Frame: 14 days ]
  • HHV-8 detection in the plasma or oropharynx [ Time Frame: 14 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2006)
  • Safety and tolerability of valganciclovir
  • Proportion of patients resolving symptoms by 4 days
  • HHV-8 detection in the plasma or oropharynx
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Valganciclovir to Treat HHV-8 Associated Multicentric Castleman's Disease
Official Title  ICMJE Clinical and Virologic Response to HHV-8 Associated Multicentric Castleman's Disease to Valganciclovir
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Giant Lymph Node Hyperplasia
Intervention  ICMJE Drug: Valganciclovir
valganciclovir open label, two 450mg tablets orally, twice a day
Other Name: Valcyte
Study Arms  ICMJE Experimental: 1
Intervention: Drug: Valganciclovir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 14, 2017)
0
Original Enrollment  ICMJE
 (submitted: August 8, 2006)
64
Estimated Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00361933
Other Study ID Numbers  ICMJE 30618
VAL096
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Corey Casper, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE Hoffmann-La Roche
Investigators  ICMJE
Principal Investigator: Corey Casper, MD, MPH University of Washington
PRS Account University of Washington
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP