Study Stopped
Research never begun.
Valganciclovir to Treat HHV-8 Associated Multicentric Castleman's Disease
Clinical and Virologic Response to HHV-8 Associated Multicentric Castleman's Disease to Valganciclovir
2 other identifiers
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2008
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2006
CompletedFirst Posted
Study publicly available on registry
August 9, 2006
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedApril 18, 2017
April 1, 2017
5 months
August 8, 2006
April 14, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Time to improvement
14 days
One-log reduction in HHV-8 peripheral blood viral load
14 days
Secondary Outcomes (3)
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
Study Arms (1)
1
EXPERIMENTALInterventions
valganciclovir open label, two 450mg tablets orally, twice a day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- Hoffmann-La Rochecollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Corey Casper, MD, MPH
University of Washington
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 8, 2006
First Posted
August 9, 2006
Study Start
December 1, 2008
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
April 18, 2017
Record last verified: 2017-04