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OpenTrials
Completed

NCT Number: NCT00129818

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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Key information

Conditions

Genital Herpes Communicable Diseases DNA Virus Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Herpes Genitalis Herpes Simplex Herpesviridae Infections Infections Male Urogenital Diseases Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Famciclovir

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Aug 12, 2005
Registry last updated
Apr 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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