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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00129818
First received: August 11, 2005
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Genital Herpes
Drug: Famciclovir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding

Resource links provided by NLM:


Further study details as provided by Novartis:

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

Study Start Date: July 2004
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129818

Locations
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
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00129818     History of Changes
Other Study ID Numbers: CFAM810A2404
Study First Received: August 11, 2005
Last Updated: April 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Genital herpes
viral shedding
famciclovir
Symptomatic genital herpes
Asymptomatic genital herpes

Additional relevant MeSH terms:
Herpes Genitalis
DNA Virus Infections
Genital Diseases, Female
Genital Diseases, Male
Herpes Simplex
Herpesviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Virus Diseases
Famciclovir
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014