Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00306787
First received: March 22, 2006
Last updated: June 28, 2011
Last verified: June 2011
  Purpose

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).


Condition Intervention Phase
Genital Herpes
Drug: Famciclovir
Drug: Valacyclovir
Drug: Placebo matching famciclovir
Drug: Placebo matching valacyclovir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions [ Time Frame: 72 hours after initiation of study medication up to Day 20 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants With Aborted Genital Herpes Lesions [ Time Frame: 72 hours after initiation of study medication up to Day 20 ] [ Designated as safety issue: No ]
    Lesions that developed no further than the papule stage (erythema may have been present) were considered as aborted lesions. Prodrome also was considered the sign of aborted lesions in this study. Lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing were considered as non-aborted lesions.

  • Investigator-assessed Time to Healing of All (Non-aborted and Aborted) Genital Herpes Lesions [ Time Frame: 72 hours after initiation of study medication up to Day 20 ] [ Designated as safety issue: No ]
    Lesions that developed no further than the papule stage (erythema may have been present) were considered as aborted lesions. Prodrome also was considered the sign of aborted lesions in this study. Lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing were considered as non-aborted lesions. The median time was estimated using Kaplan-Meier method.

  • Time to Resolution of Symptoms Associated With Recurrent Genital Herpes [ Time Frame: 72 hours after initiation of study medication up to Day 20 ] [ Designated as safety issue: No ]
    Kaplan-Meier estimated time in hours of the resolution of all symptoms (pain, burning, itching, tingling and tenderness) associated with recurrent genital herpes. Kaplan-Meier method is used to estimate the time to resolution of symptoms.

  • Number of Patients With a Second Recurrence of Genital Herpes [ Time Frame: Up to 6 months after investigator assessed healing of first recurrence of genital herpes ] [ Designated as safety issue: No ]
    Patients who experienced a first recurrence of genital herpes and took study medication were followed for a period of up to 6 months to the second recurrence.

  • Time to a Second Recurrence of Genital Herpes [ Time Frame: Up to 6 months after investigator assessed healing of first recurrence of genital herpes ] [ Designated as safety issue: No ]

    Patients who experienced a first recurrence of genital herpes and took study medication were followed for a period of up to 6 months to the second recurrence. Time to a second recurrence of genital herpes was calculated in 2 ways as follows:

    1. From the date of treatment initiation no earlier than the recurrence of genital herpes to the date of onset for the second recurrence, or
    2. From the date of healing of non-aborted lesions or confirmation of aborted lesions to the date of onset for the second recurrence.


Enrollment: 1179
Study Start Date: March 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Famciclovir
Famciclovir 500 mg tablet
Other Name: Famvir
Drug: Placebo matching valacyclovir
Valacyclovir placebo, matching in size, color and forms of valacyclovir capsule.
Active Comparator: 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.
Drug: Valacyclovir
Valacyclovir 500 mg capsule
Other Name: Valtrex
Drug: Placebo matching famciclovir
Famciclovir placebo, matching in size, color and forms of famciclovir tablet.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306787

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Novartis Investigative Site
Chandler, Arizona, United States, 85225
Women's Health Research
Phoenix, Arizona, United States, 85015
Quality of Life Medical & Research Center, LLC
Tucson, Arizona, United States, 85712
United States, Arkansas
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
NEA Women's Clinic
Jonesboro, Arkansas, United States, 72401
The Woman's Clinic
Little Rock, Arkansas, United States, 72205
United States, California
Providence Clinical Research
Burbank, California, United States, 91505
Dermatology Research Associates
Los Angeles, California, United States, 90045
Sacramento Research Medical Group
Sacramento, California, United States, 95825
North California Research Corp.
Sacramento, California, United States, 95831
Medical Center for Clinical Research
San Diego, California, United States, 92108
Conant Research
San Francisco, California, United States, 94114
United States, Colorado
Barbara Davis Center
Denver, Colorado, United States, 80262
Cohen & Womack, P.C.
Lakewood, Colorado, United States, 80228
United States, Florida
Visions Clinical Research
Boynton Beach, Florida, United States, 33437
Women's Medical Research Group, LLC
Clearwater, Florida, United States, 33759
International Research Association LLC
Miami, Florida, United States, 33156
Orlando Clinical Research Ctr.
Orlando, Florida, United States, 32809
University Clinical Research, Inc.
Pembroke Pines, Florida, United States, 33024
Avancia Research
Pembroke Pines, Florida, United States, 33024
Palm Beach Research Center
West Palm Beach, Florida, United States, 33409
United States, Georgia
Mount Vernon Clinical Research
Atlanta, Georgia, United States, 30328
United States, Indiana
Medisphere Medical Research Center, LLC.
Evansville, Indiana, United States, 47714
Indiana University Infectious Disease Research Group
Indianapolis, Indiana, United States, 46202
United States, Kansas
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67207
United States, Kentucky
Common Wealth Biomedical Research
Madisonville, Kentucky, United States, 42431
United States, Maryland
SNBL Clinical Pharmacology Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Future Care Studies
Springfield, Massachusetts, United States, 01107
United States, Missouri
Clayton Research Institute
St. Louis, Missouri, United States, 63117
United States, Montana
Deaconess Billings Clinic Research Center
Billings, Montana, United States, 59101
United States, Nebraska
Heartland Clinical Research, Inc.
Omaha, Nebraska, United States, 68134
United States, North Carolina
UNC Clinical Research.
Raleigh, North Carolina, United States, 27607
Hawthorne Medical Research, Inc.
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Providence Health Partners-Center for Clinical Research
Dayton, Ohio, United States, 45439
United States, Oklahoma
Lynne Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Westover Heights Clinic
Portland, Oregon, United States, 97210
United States, Pennsylvania
Paddington Testing Co. Inc
Philadelphia, Pennsylvania, United States, 19103
Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
S. Carolina Clinical Research Center
Columbia, South Carolina, United States, 29201
Research Inc.
Florence, South Carolina, United States, 29501
Palmetto Clinical Trial Services, LLC
Simpsonville, South Carolina, United States, 29681
United States, Texas
Benchmark Research
Austin, Texas, United States, 78705
Renaissance Clinical Research and Hypertension Clinic
Dallas, Texas, United States, 75235
Center for Clinical Studies (TX Medical Center)
Houston, Texas, United States, 77030
Center for Clinical Studies
Houston, Texas, United States, 77058
United States, Utah
University of Utah-School of Medicine (Div. of Inf. Disease)
Salt Lake City, Utah, United States, 84132
Salt Lake Women's Center/Physician's Research Options
Sandy, Utah, United States, 84070
United States, Virginia
Clinical Trials of Virginia, Inc.
Richmond, Virginia, United States, 23225
United States, Washington
University of Washington, Virology Research Clinic
Seattle, Washington, United States, 98122
Liberty Research Center
Tacoma, Washington, United States, 98405
Australia, New South Wales
Novartis Investigative Site
Darlinghurst, New South Wales, Australia, 2010
Canada, Alberta
Novartis Investigational Site
Edmonton, Alberta, Canada, T6G 2B6
Canada, British Columbia
Novartis Investigational Site
Vancouver, British Columbia, Canada, V6Z 2C7
Canada, Manitoba
Novartis Investigational Site
Winnipeg, Manitoba, Canada, R3E 0W3
Canada, Ontario
Novartis Investigational Site
Markham, Ontario, Canada, L3P 1A8
Novartis Investigational Site
Ottawa, Ontario, Canada, K1S 0G8
Canada, Quebec
Novartis Investigational Site
Laval, Quebec, Canada, H7X 3S5
Novartis Investigational Site
Montréal, Quebec, Canada, H2K 4L5
Novartis Investigational Site
Montréal, Quebec, Canada, H3H IV4
Novartis Investigational Site
Sainte-Foy, Quebec, Canada, G1V 4G2
Germany
Novartis Investigational Site
Augsburg, Germany, D-86179
Novartis Investigational Site
Berlin, Germany
Novartis Investigational Site
Freiburg, Germany, 79106
Novartis Investigational Site
Rostock, Germany, D-18055
Novartis Investigational Site
Wolfsburg, Germany, D-38440
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00306787     History of Changes
Other Study ID Numbers: CFAM810A2308
Study First Received: March 22, 2006
Results First Received: August 20, 2009
Last Updated: June 28, 2011
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Novartis:
Herpes simplex
genital herpes
famciclovir
valacyclovir
Recurrent genital herpes

Additional relevant MeSH terms:
Herpes Genitalis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Famciclovir
Valacyclovir
Acyclovir
2-Aminopurine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014