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A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding

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: NCT00129818
Recruitment Status : Completed
First Posted : August 12, 2005
Last Update Posted : April 27, 2012
Sponsor:
Information provided by:
Novartis

Study Description
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Brief Summary:
The study is designed to assess the efficacy and safety of famciclovir 250 mg twice a day (bid) suppressive treatment in men and women with herpes virus type 2 (HSV-2) infection, with and without a reported history of genital herpes and with or without herpes virus type 1 (HSV-1) seropositivity.

Condition or disease Intervention/treatment Phase
Genital Herpes Drug: Famciclovir Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding
Study Start Date : July 2004
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genital Herpes
Drug Information available for: Famciclovir

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Group 1. Reduction of HSV DNA PCR positive days in HSV-2 seropositive patients with a history of clinical genital herpes lesions
  2. Group 2. Reduction of HSV DNA PCR positive days in HSV-2 seropositive patients without a history of clinical genital herpes lesions

Secondary Outcome Measures :
  1. reduction of HSV DNA PCR positive days without lesions in HSV-2 seropositive patients with and without a history of clinical genital herpes lesions
  2. quantitative HSV DNA PCR, during the days with positive HSV-2 shedding.
  3. time to the first recurrence of genital herpes and number of genital herpes recurrence episodes
  4. oral HSV-1 and/or HSV-2 shedding in HSV-1 and HSV-2 seropositive patients
  5. reduction of HSV DNA PCR positive days with lesions in HSV-2 seropositive patients with and without a history of clinical genital herpes lesions

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Males or non-pregnant females at least 18 years of age with HSV-2 seropositive serology with or without history of clinically diagnosed recurrent genital herpes

Exclusion Criteria:

  • Pregnancy
  • History of renal dysfunction
  • Use of immunosuppressive therapy, including steroids (other than topical or inhaled), or use of probenecid
  • Hypersensitivity to famciclovir, valacyclovir or drugs with similar chemical structure
Contacts and Locations
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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): NCT00129818


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Florida
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
United States, Indiana
IU Center for Clinical STD Research
Indianapolis, Indiana, United States, 46202
United States, North Carolina
UNC Clinical Research - Raleigh
Raleigh, North Carolina, United States, 27607
United States, Oklahoma
Lynne Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Westover Heights Clinic
Portland, Oregon, United States, 97210
United States, Washington
University of Washington - Virology Research Clinic
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Novartis
Investigators
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Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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ClinicalTrials.gov Identifier: NCT00129818    
Other Study ID Numbers: CFAM810A2404
First Posted: August 12, 2005    Key Record Dates
Last Update Posted: April 27, 2012
Last Verified: April 2012
Keywords provided by Novartis:
Genital herpes
viral shedding
famciclovir
Symptomatic genital herpes
Asymptomatic genital herpes
Additional relevant MeSH terms:
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Herpes Genitalis
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Herpes Simplex
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
 Genital Diseases, Female
Famciclovir
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action