Suppression of Oral HHV8 Shedding With Valganciclovir

Human Herpesvirus 8 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00194467
• Other study ID #: 02-1500-B
• Secondary ID: VAL041
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: December 29, 2007
• Start date: December 2002
• Est. completion date: March 2005

Study information

• Verified date: December 2007
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Human Herpesvirus 8

Intervention

Drug:
• valganciclovir
900 mg once a day for 8 weeks
• placebo
matching placebo, once a day for 8 weeks

Locations

Country	Name	City	State
United States	University of Washington Virology Research Clinic	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The frequency of neutropenia, defined as ANC less than 500. The frequency of thrombocytopenia, defined as platelets less than 75,000.		19 weeks	Yes