Genital Herpes
Conditions
Keywords
Genital herpes, viral shedding, famciclovir, Symptomatic genital herpes, Asymptomatic genital herpes
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.
Interventions
DRUGFamciclovir
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| time to the first recurrence of genital herpes and number of genital herpes recurrence episodes | — |
| reduction of HSV DNA PCR positive days without lesions in HSV-2 seropositive patients with and without a history of clinical genital herpes lesions | — |
| reduction of HSV DNA PCR positive days with lesions in HSV-2 seropositive patients with and without a history of clinical genital herpes lesions | — |
| oral HSV-1 and/or HSV-2 shedding in HSV-1 and HSV-2 seropositive patients | — |
| quantitative HSV DNA PCR, during the days with positive HSV-2 shedding. | — |
Countries
United States
Outcome results
None listed