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

Giant Lymph Node Hyperplasia Clinical Trial

Official title:

Clinical and Virologic Response to HHV-8 Associated Multicentric Castleman's Disease to Valganciclovir

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00361933
• Other study ID #: 30618
• Secondary ID: VAL096
• Status: Withdrawn
• Phase: Phase 4
• First received: August 8, 2006
• Last updated: April 14, 2017
• Start date: December 2008
• Est. completion date: May 2009

Study information

• Verified date: April 2017
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Giant Lymph Node Hyperplasia
• Hyperplasia

Intervention

Drug:
• Valganciclovir
valganciclovir open label, two 450mg tablets orally, twice a day

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Hoffmann-La Roche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to improvement		14 days
Primary	One-log reduction in HHV-8 peripheral blood viral load		14 days
Secondary	Safety and tolerability of valganciclovir		14 days
Secondary	Proportion of patients resolving symptoms by 4 days		14 days
Secondary	HHV-8 detection in the plasma or oropharynx		14 days