Suppression of Oral HHV8 Shedding With Valganciclovir

Suppression of Oral Shedding of Human Herpesvirus 8 (HHV-8) With Valganciclovir

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.

Study Overview

• Status: Completed
• Conditions: Human Herpesvirus 8
• Intervention / Treatment: Drug: valganciclovir; Drug: placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98122
      • University of Washington Virology Research Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 2	Drug: placebo; matching placebo, once a day for 8 weeks
EXPERIMENTAL: 1	Drug: valganciclovir; 900 mg once a day for 8 weeks; Other Names: Valcyte

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	19 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
The frequency of neutropenia, defined as ANC less than 500. The frequency of thrombocytopenia, defined as platelets less than 75,000.	19 weeks

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: December 1, 2002
• Primary Completion (ACTUAL): March 1, 2005
• Study Completion (ACTUAL): March 1, 2005

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (ESTIMATE): September 19, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): January 10, 2008
• Last Update Submitted That Met QC Criteria: December 29, 2007
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Antiviral Agents; Valganciclovir
• Other Study ID Numbers: 02-1500-B; VAL041