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.
|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|
- 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 ]
- 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 ]
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
valganciclovir open label, two 450mg tablets orally, twice a day
Other Name: Valcyte
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00361933
|Principal Investigator:||Corey Casper, MD, MPH||University of Washington|