Suppression of Oral HHV8 Shedding With Valganciclovir

NCT00194467 | Completed Phase 2 DMC

• 2 other identifiers: 02-1500-BVAL041
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Human Herpesvirus 8

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The frequency of neutropenia, defined as ANC less than 500. The frequency of thrombocytopenia, defined as platelets less than 75,000.

  19 weeks

Study Arms (2)

1

EXPERIMENTAL

Drug: valganciclovir

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

valganciclovir DRUG

900 mg once a day for 8 weeks

Also known as: Valcyte

1

placebo DRUG

matching placebo, once a day for 8 weeks

2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

University of Washington Virology Research Clinic

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Sarcoma, Kaposi

Interventions

Valganciclovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue

Intervention Hierarchy (Ancestors)

Ganciclovir; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Anna Wald, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: December 1, 2002
• Primary Completion: March 1, 2005
• Study Completion: March 1, 2005
• Last Updated: January 10, 2008

Record last verified: 2007-12

Locations

US (1)