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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00361933
• Date of registration: 08/08/2006
• Prospective Registration: Yes
• Primary sponsor: University of Washington
• Public title: Valganciclovir to Treat HHV-8 Associated Multicentric Castleman's Disease
• Scientific title: Clinical and Virologic Response to HHV-8 Associated Multicentric Castleman's Disease to Valganciclovir
• Date of first enrolment: December 2008
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT00361933
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Corey Casper, MD, MPH
• Affiliation: University of Washington

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Giant Lymph Node Hyperplasia

Intervention(s)

Drug: Valganciclovir

Primary Outcome(s)

Time to improvement [Time Frame: 14 days]

One-log reduction in HHV-8 peripheral blood viral load [Time Frame: 14 days]

Secondary Outcome(s)

HHV-8 detection in the plasma or oropharynx [Time Frame: 14 days]

Proportion of patients resolving symptoms by 4 days [Time Frame: 14 days]

Safety and tolerability of valganciclovir [Time Frame: 14 days]

Secondary ID(s)

30618

VAL096

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hoffmann-La Roche