Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes
NCT ID: NCT00306787
Last Updated: 2011-06-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
1179 participants
INTERVENTIONAL
2006-03-31
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Famciclovir
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.
Famciclovir
Famciclovir 500 mg tablet
Placebo matching valacyclovir
Valacyclovir placebo, matching in size, color and forms of valacyclovir capsule.
Valacyclovir
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.
Valacyclovir
Valacyclovir 500 mg capsule
Placebo matching famciclovir
Famciclovir placebo, matching in size, color and forms of famciclovir tablet.
Interventions
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Famciclovir
Famciclovir 500 mg tablet
Valacyclovir
Valacyclovir 500 mg capsule
Placebo matching famciclovir
Famciclovir placebo, matching in size, color and forms of famciclovir tablet.
Placebo matching valacyclovir
Valacyclovir placebo, matching in size, color and forms of valacyclovir capsule.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Novartis Pharmaceuticals
Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Novartis Investigative Site
Chandler, Arizona, United States
Women's Health Research
Phoenix, Arizona, United States
Quality of Life Medical & Research Center, LLC
Tucson, Arizona, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
NEA Women's Clinic
Jonesboro, Arkansas, United States
The Woman's Clinic
Little Rock, Arkansas, United States
Providence Clinical Research
Burbank, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Sacramento Research Medical Group
Sacramento, California, United States
North California Research Corp.
Sacramento, California, United States
Medical Center for Clinical Research
San Diego, California, United States
Conant Research
San Francisco, California, United States
Barbara Davis Center
Denver, Colorado, United States
Cohen & Womack, P.C.
Lakewood, Colorado, United States
Visions Clinical Research
Boynton Beach, Florida, United States
Women's Medical Research Group, LLC
Clearwater, Florida, United States
International Research Association LLC
Miami, Florida, United States
Orlando Clinical Research Ctr.
Orlando, Florida, United States
Avancia Research
Pembroke Pines, Florida, United States
University Clinical Research, Inc.
Pembroke Pines, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Mount Vernon Clinical Research
Atlanta, Georgia, United States
Medisphere Medical Research Center, LLC.
Evansville, Indiana, United States
Indiana University Infectious Disease Research Group
Indianapolis, Indiana, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Common Wealth Biomedical Research
Madisonville, Kentucky, United States
SNBL Clinical Pharmacology Center
Baltimore, Maryland, United States
Future Care Studies
Springfield, Massachusetts, United States
Clayton Research Institute
St Louis, Missouri, United States
Deaconess Billings Clinic Research Center
Billings, Montana, United States
Heartland Clinical Research, Inc.
Omaha, Nebraska, United States
UNC Clinical Research.
Raleigh, North Carolina, United States
Hawthorne Medical Research, Inc.
Winston-Salem, North Carolina, United States
Providence Health Partners-Center for Clinical Research
Dayton, Ohio, United States
Lynne Health Science Institute
Oklahoma City, Oklahoma, United States
Westover Heights Clinic
Portland, Oregon, United States
Paddington Testing Co. Inc
Philadelphia, Pennsylvania, United States
Magee Womens Hospital
Pittsburgh, Pennsylvania, United States
S. Carolina Clinical Research Center
Columbia, South Carolina, United States
Research Inc.
Florence, South Carolina, United States
Palmetto Clinical Trial Services, LLC
Simpsonville, South Carolina, United States
Benchmark Research
Austin, Texas, United States
Renaissance Clinical Research and Hypertension Clinic
Dallas, Texas, United States
Center for Clinical Studies (TX Medical Center)
Houston, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
University of Utah-School of Medicine (Div. of Inf. Disease)
Salt Lake City, Utah, United States
Salt Lake Women's Center/Physician's Research Options
Sandy City, Utah, United States
Clinical Trials of Virginia, Inc.
Richmond, Virginia, United States
University of Washington, Virology Research Clinic
Seattle, Washington, United States
Liberty Research Center
Tacoma, Washington, United States
Novartis Investigative Site
Darlinghurst, New South Wales, Australia
Novartis Investigational Site
Edmonton, Alberta, Canada
Novartis Investigational Site
Vancouver, British Columbia, Canada
Novartis Investigational Site
Winnipeg, Manitoba, Canada
Novartis Investigational Site
Markham, Ontario, Canada
Novartis Investigational Site
Ottawa, Ontario, Canada
Novartis Investigational Site
Laval, Quebec, Canada
Novartis Investigational Site
Montreal, Quebec, Canada
Novartis Investigational Site
Montreal, Quebec, Canada
Novartis Investigational Site
Sainte-Foy, Quebec, Canada
Novartis Investigational Site
Augsburg, , Germany
Novartis Investigational Site
Berlin, , Germany
Novartis Investigational Site
Freiburg im Breisgau, , Germany
Novartis Investigational Site
Rostock, , Germany
Novartis Investigational Site
Wolfsburg, , Germany
Countries
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References
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Bodsworth N, Fife K, Koltun W, Tyring S, Abudalu M, Prichard M, Hamed K. Single-day famciclovir for the treatment of genital herpes: follow-up results of time to next recurrence and assessment of antiviral resistance. Curr Med Res Opin. 2009 Feb;25(2):483-7. doi: 10.1185/03007990802664678.
Related Links
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Other Identifiers
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CFAM810A2308
Identifier Type: -
Identifier Source: org_study_id