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

August 11, 2005
April 26, 2012
July 2004
October 2005   (final data collection date for primary outcome measure)
  • 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
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Complete list of historical versions of study NCT00129818 on ClinicalTrials.gov Archive Site
  • 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
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A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding
A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding

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.

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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Genital Herpes
Drug: Famciclovir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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October 2005
October 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
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Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00129818
CFAM810A2404
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Novartis
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Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP