A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding
- Conditions
- Genital Herpes
- Registration Number
- NCT00129818
- Lead Sponsor
- Novartis
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (7)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Orlando Clinical Research Center
🇺🇸Orlando, Florida, United States
IU Center for Clinical STD Research
🇺🇸Indianapolis, Indiana, United States
Lynne Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
UNC Clinical Research - Raleigh
🇺🇸Raleigh, North Carolina, United States
Westover Heights Clinic
🇺🇸Portland, Oregon, United States
University of Washington - Virology Research Clinic
🇺🇸Seattle, Washington, United States