Suppression of Oral HHV8 Shedding With Valganciclovir

Completed · Phase 2 · Has a placebo group

Conditions studied: Human Herpesvirus 8

In brief

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.

Key facts

Study ID

NCT00194467

Run by

University of Washington

People needed

32

Starts

2002-12-01

Expected to finish

2005-03-01

Last updated by the study team

2008-01-10

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Washington Virology Research Clinic — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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