Status:
COMPLETED
Suppression of Oral HHV8 Shedding With Valganciclovir
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Human Herpesvirus 8
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of the study is to use valganciclovir to define the role of antiviral therapy in suppression of HHV-8 shedding in HHV-8 seropositive men. Our hypothesis is that valganciclovir will substan...
Detailed Description
The purpose of the study is to use valganciclovir to define the role of antiviral therapy in suppression of HHV-8 shedding in HHV-8 seropositive men. Our hypothesis is that valganciclovir will substan...
Eligibility Criteria
Inclusion
- 18 years or older
- HHV-8 seropositive or previous evidence of HHV-8 shedding
- a frequent shedder of HHV-8
- not receiving any drugs with known anti-HHV-8 activity for study duration
- able to comply with the study protocol
- agree to HIV testing
Exclusion
- history of evidence of CMV disease
- hypersensitivity to ganciclovir or valganciclovir
- use of high-dose acyclovir, valacyclovir, famciclovir, ganciclovir, foscarnet, or cidofovir
- neutropenia
- renal insufficiency with serum creatinine greater than 1.5mg.ml or CrCl less than 60
- AST or ALT greater than 5 times upper limit of normal
- concurrent administration of medications which are often associated with severe neutropenia or thrombocytopenia
- concurrent administration of probenecid or didanosine
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00194467
Start Date
December 1 2002
End Date
March 1 2005
Last Update
January 10 2008
Active Locations (1)
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1
University of Washington Virology Research Clinic
Seattle, Washington, United States, 98122