Valganciclovir to Treat HHV-8 Associated Multicentric Castleman's Disease
Stopped: Research never begun.
0Started 2008-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to improvement
Timeframe: 14 days
2
One-log reduction in HHV-8 peripheral blood viral load