Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes
A Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Patient-initiated Famciclovir 1000 mg b.i.d. x 1 Day to Valacyclovir 500 mg b.i.d. x 3 Days in Immunocompetent Adults With Recurrent Genital Herpes
1 other identifier
interventional
1,179
4 countries
66
Brief Summary
This study will assess the safety and efficacy of one-day famciclovir (1000 mg twice a day (b.i.d)) in reducing the duration of genital herpes lesions and the associated symptoms compared to three-day treatment with valacyclovir (500 mg capsule b.i.d).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2006
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 22, 2006
CompletedFirst Posted
Study publicly available on registry
March 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedResults Posted
Study results publicly available
June 17, 2011
CompletedJune 30, 2011
June 1, 2011
1.9 years
March 22, 2006
August 20, 2009
June 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions
Time to healing of all non-aborted genital herpes lesions was defined as the time from the first dose of study drug taken no earlier than the recurrence of genital herpes to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of the lesions; erythema could have been present). Non-aborted lesions are lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing. The median time was estimated using Kaplan-Meier method by censoring missing values at the time of last clinical lesion observation.
72 hours after initiation of study medication up to Day 20
Secondary Outcomes (5)
Percentage of Participants With Aborted Genital Herpes Lesions
72 hours after initiation of study medication up to Day 20
Investigator-assessed Time to Healing of All (Non-aborted and Aborted) Genital Herpes Lesions
72 hours after initiation of study medication up to Day 20
Time to Resolution of Symptoms Associated With Recurrent Genital Herpes
72 hours after initiation of study medication up to Day 20
Number of Patients With a Second Recurrence of Genital Herpes
Up to 6 months after investigator assessed healing of first recurrence of genital herpes
Time to a Second Recurrence of Genital Herpes
Up to 6 months after investigator assessed healing of first recurrence of genital herpes
Study Arms (2)
Famciclovir
EXPERIMENTALPatients 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.
Valacyclovir
ACTIVE COMPARATORPatients 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.
Interventions
Famciclovir placebo, matching in size, color and forms of famciclovir tablet.
Valacyclovir placebo, matching in size, color and forms of valacyclovir capsule.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (66)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Novartis Investigative Site
Chandler, Arizona, 85225, United States
Women's Health Research
Phoenix, Arizona, 85015, United States
Quality of Life Medical & Research Center, LLC
Tucson, Arizona, 85712, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913, United States
NEA Women's Clinic
Jonesboro, Arkansas, 72401, United States
The Woman's Clinic
Little Rock, Arkansas, 72205, United States
Providence Clinical Research
Burbank, California, 91505, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Sacramento Research Medical Group
Sacramento, California, 95825, United States
North California Research Corp.
Sacramento, California, 95831, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
Conant Research
San Francisco, California, 94114, United States
Barbara Davis Center
Denver, Colorado, 80262, United States
Cohen & Womack, P.C.
Lakewood, Colorado, 80228, United States
Visions Clinical Research
Boynton Beach, Florida, 33437, United States
Women's Medical Research Group, LLC
Clearwater, Florida, 33759, United States
International Research Association LLC
Miami, Florida, 33156, United States
Orlando Clinical Research Ctr.
Orlando, Florida, 32809, United States
Avancia Research
Pembroke Pines, Florida, 33024, United States
University Clinical Research, Inc.
Pembroke Pines, Florida, 33024, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Mount Vernon Clinical Research
Atlanta, Georgia, 30328, United States
Medisphere Medical Research Center, LLC.
Evansville, Indiana, 47714, United States
Indiana University Infectious Disease Research Group
Indianapolis, Indiana, 46202, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67207, United States
Common Wealth Biomedical Research
Madisonville, Kentucky, 42431, United States
SNBL Clinical Pharmacology Center
Baltimore, Maryland, 21201, United States
Future Care Studies
Springfield, Massachusetts, 01107, United States
Clayton Research Institute
St Louis, Missouri, 63117, United States
Deaconess Billings Clinic Research Center
Billings, Montana, 59101, United States
Heartland Clinical Research, Inc.
Omaha, Nebraska, 68134, United States
UNC Clinical Research.
Raleigh, North Carolina, 27607, United States
Hawthorne Medical Research, Inc.
Winston-Salem, North Carolina, 27103, United States
Providence Health Partners-Center for Clinical Research
Dayton, Ohio, 45439, United States
Lynne Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Westover Heights Clinic
Portland, Oregon, 97210, United States
Paddington Testing Co. Inc
Philadelphia, Pennsylvania, 19103, United States
Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
S. Carolina Clinical Research Center
Columbia, South Carolina, 29201, United States
Research Inc.
Florence, South Carolina, 29501, United States
Palmetto Clinical Trial Services, LLC
Simpsonville, South Carolina, 29681, United States
Benchmark Research
Austin, Texas, 78705, United States
Renaissance Clinical Research and Hypertension Clinic
Dallas, Texas, 75235, United States
Center for Clinical Studies (TX Medical Center)
Houston, Texas, 77030, United States
Center for Clinical Studies
Houston, Texas, 77058, United States
University of Utah-School of Medicine (Div. of Inf. Disease)
Salt Lake City, Utah, 84132, United States
Salt Lake Women's Center/Physician's Research Options
Sandy City, Utah, 84070, United States
Clinical Trials of Virginia, Inc.
Richmond, Virginia, 23225, United States
University of Washington, Virology Research Clinic
Seattle, Washington, 98122, United States
Liberty Research Center
Tacoma, Washington, 98405, United States
Novartis Investigative Site
Darlinghurst, New South Wales, 2010, Australia
Novartis Investigational Site
Edmonton, Alberta, T6G 2B6, Canada
Novartis Investigational Site
Vancouver, British Columbia, V6Z 2C7, Canada
Novartis Investigational Site
Winnipeg, Manitoba, R3E 0W3, Canada
Novartis Investigational Site
Markham, Ontario, L3P 1A8, Canada
Novartis Investigational Site
Ottawa, Ontario, K1S 0G8, Canada
Novartis Investigational Site
Laval, Quebec, H7X 3S5, Canada
Novartis Investigational Site
Montreal, Quebec, H2K 4L5, Canada
Novartis Investigational Site
Montreal, Quebec, H3H IV4, Canada
Novartis Investigational Site
Sainte-Foy, Quebec, G1V 4G2, Canada
Novartis Investigational Site
Augsburg, D-86179, Germany
Novartis Investigational Site
Berlin, Germany
Novartis Investigational Site
Freiburg im Breisgau, 79106, Germany
Novartis Investigational Site
Rostock, D-18055, Germany
Novartis Investigational Site
Wolfsburg, D-38440, Germany
Related Publications (1)
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.
PMID: 19192993DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 22, 2006
First Posted
March 24, 2006
Study Start
March 1, 2006
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
June 30, 2011
Results First Posted
June 17, 2011
Record last verified: 2011-06