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