Status:
WITHDRAWN
Valganciclovir to Treat HHV-8 Associated Multicentric Castleman's Disease
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Giant Lymph Node Hyperplasia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
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 pa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00361933
Start Date
December 1 2008
End Date
May 1 2009
Last Update
April 18 2017
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