Suppression of Oral HHV8 Shedding With Valganciclovir

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: Male

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 substantially reduce the frequency of detection and amount of HHV-8 in the mouth.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborator: Hoffmann-La Roche
• Treatments: Ganciclovir; Valganciclovir

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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