Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes
Genital Herpes
About this trial
This is an interventional treatment trial for Genital Herpes focused on measuring Herpes simplex, genital herpes, famciclovir, valacyclovir, Recurrent genital herpes
Eligibility Criteria
Inclusion Criteria: At least 18 years old History of at least 4 recurrences of genital herpes in the preceding 12 months Lesions located on the external genitalia or anogenital region Willing to discontinue suppressive treatment Documented positive herpes simplex virus (HSV) General good health, and history of normal renal function Exclusion Criteria: Women of childbearing potential not using approved form of contraceptive Pregnant or nursing women History of hypersensitivity to famciclovir, valacyclovir, or acyclovir Known to be immunosuppressed Known to have renal dysfunction Receiving anti-herpes therapy Known to have other genital tract disorders Known to have condition which could interfere with drug absorption Additional protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
- University of Alabama at Birmingham
- Novartis Investigative Site
- Women's Health Research
- Quality of Life Medical & Research Center, LLC
- Burke Pharmaceutical Research
- NEA Women's Clinic
- The Woman's Clinic
- Providence Clinical Research
- Dermatology Research Associates
- Sacramento Research Medical Group
- North California Research Corp.
- Medical Center for Clinical Research
- Conant Research
- Barbara Davis Center
- Cohen & Womack, P.C.
- Visions Clinical Research
- Women's Medical Research Group, LLC
- International Research Association LLC
- Orlando Clinical Research Ctr.
- Avancia Research
- University Clinical Research, Inc.
- Palm Beach Research Center
- Mount Vernon Clinical Research
- Medisphere Medical Research Center, LLC.
- Indiana University Infectious Disease Research Group
- Heartland Research Associates, LLC
- Common Wealth Biomedical Research
- SNBL Clinical Pharmacology Center
- Future Care Studies
- Clayton Research Institute
- Deaconess Billings Clinic Research Center
- Heartland Clinical Research, Inc.
- UNC Clinical Research.
- Hawthorne Medical Research, Inc.
- Providence Health Partners-Center for Clinical Research
- Lynne Health Science Institute
- Westover Heights Clinic
- Paddington Testing Co. Inc
- Magee Womens Hospital
- S. Carolina Clinical Research Center
- Research Inc.
- Palmetto Clinical Trial Services, LLC
- Benchmark Research
- Renaissance Clinical Research and Hypertension Clinic
- Center for Clinical Studies (TX Medical Center)
- Center for Clinical Studies
- University of Utah-School of Medicine (Div. of Inf. Disease)
- Salt Lake Women's Center/Physician's Research Options
- Clinical Trials of Virginia, Inc.
- University of Washington, Virology Research Clinic
- Liberty Research Center
- Novartis Investigative Site
- Novartis Investigational Site
- Novartis Investigational Site
- Novartis Investigational Site
- Novartis Investigational Site
- Novartis Investigational Site
- Novartis Investigational Site
- Novartis Investigational Site
- Novartis Investigational Site
- Novartis Investigational Site
- Novartis Investigational Site
- Novartis Investigational Site
- Novartis Investigational Site
- Novartis Investigational Site
- Novartis Investigational Site
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Famciclovir
Valacyclovir
Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
Patients received Valacyclovir 500 mg capsule twice a day approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.