Clinical Trial: A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding
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.
Detailed Summary:
Sponsor: Novartis
Current Primary Outcome:
- 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
Original Primary Outcome:
Current Secondary Outcome:
- 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
Original Secondary Outcome:
Information By: Novartis
Dates:
Date Received: August 11, 2005
Date Started: July 2004
Date Completion:
Last Updated: April 26, 2012
Last Verified: April 2012
