Suppression of Oral HHV8 Shedding With Valganciclovir
Information source: University of Washington
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Human Herpesvirus 8
Intervention: valganciclovir (Drug); placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of Washington Official(s) and/or principal investigator(s): Anna Wald, MD, MPH, Principal Investigator, Affiliation: University of Washington
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.
Clinical Details
Official title: Suppression of Oral Shedding of Human Herpesvirus 8 (HHV-8) With Valganciclovir
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: The reduction in percent days on which HHV-8 is detected on versus off valganciclovir. The quantitative reduction in the HHV-8 DNA detected by PCR on versus off valganciclovir.
Secondary outcome: The frequency of neutropenia, defined as ANC less than 500. The frequency of thrombocytopenia, defined as platelets less than 75,000.
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 substantially reduce the frequency of detection and amount of HHV-8 in
the mouth. Such reduction will serve to confirm that the mouth is the site of active HHV-8
replication. If valganciclovir is found to be effective, the findings from this proposal
would serve as the basis for a clinical trial with valganciclovir for prevention of Kaposi's
Sarcoma (KS) in high-risk HHV-8 seropositive persons.
After informed consent, all subjects will undergo medical history, physical examination and
screening laboratory examination. Eligible patients will return to clinic for randomization
to receiver either valganciclovir 900 mg qd or placebo. Participants will receive a diary
for noting adverse events and concurrent medications. The clinician will instruct the
participants on collection of mouth swabs and provide Dacron swabs, vials with PCR media and
pre-printed labels. Subjects will be asked to obtain a swab of oral mucosa every morning.
Clinic visits every other week will serve to review interim medical history and diaries for
adverse events, collect PCR swabs, dispense additional medication and draw safety labs. The
study uses a double-blind, randomized placebo design. Therefore, participants will not know
whether they will be taking a placebo or active medication at any time during the study.
Due to the crossover study design, however, all participants will receive the same amount of
placebo and study drug over the duration.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
University of Washington Virology Research Clinic, Seattle, Washington 98122, United States
Additional Information
Starting date: December 2002
Last updated: December 29, 2007
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