Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 15 of 101 for:    Valcyte

Suppression of Oral HHV8 Shedding With Valganciclovir

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00194467
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : January 10, 2008
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
University of Washington

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.

Condition or disease Intervention/treatment Phase
Human Herpesvirus 8 Drug: valganciclovir Drug: placebo Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Suppression of Oral Shedding of Human Herpesvirus 8 (HHV-8) With Valganciclovir
Study Start Date : December 2002
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kaposi Sarcoma

Arm Intervention/treatment
Experimental: 1 Drug: valganciclovir
900 mg once a day for 8 weeks
Other Name: Valcyte

Placebo Comparator: 2 Drug: placebo
matching placebo, once a day for 8 weeks




Primary Outcome Measures :
  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. [ Time Frame: 19 weeks ]

Secondary Outcome Measures :
  1. The frequency of neutropenia, defined as ANC less than 500. The frequency of thrombocytopenia, defined as platelets less than 75,000. [ Time Frame: 19 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00194467


Locations
Layout table for location information
United States, Washington
University of Washington Virology Research Clinic
Seattle, Washington, United States, 98122
Sponsors and Collaborators
University of Washington
Hoffmann-La Roche
Investigators
Layout table for investigator information
Principal Investigator: Anna Wald, MD, MPH University of Washington

Layout table for additonal information
Responsible Party: Corey Casper, MD, MPH, University of Washington
ClinicalTrials.gov Identifier: NCT00194467     History of Changes
Other Study ID Numbers: 02-1500-B
VAL041
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: January 10, 2008
Last Verified: December 2007

Additional relevant MeSH terms:
Layout table for MeSH terms
Valganciclovir
Antiviral Agents
Anti-Infective Agents