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

Condition(s) targeted: Genital Herpes

Intervention: Famciclovir (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Novartis

There is no known cure for genital herpes. This study will assess the safety and efficacy of one-day famciclovir in reducing the duration of genital herpes lesions and the associated symptoms compared to three-day treatment with valacyclovir.

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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: time to healing of non-aborted genital herpes lesions in patients with recurrent genital herpes

Secondary outcome:

safety assessed by adverse events (AEs)

proportion of patients aborting genital herpes lesions in patients with recurrent genital herpes

time to healing of all (non-aborted and aborted) genital herpes lesions

time to resolution of symptoms associated with recurrent genital herpes

frequency of patients with a second recurrence and time to second recurrence of genital herpes

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Novartis Investigational Site, Berlin, Germany

Novartis Investigational Site, Freiburg 79106, Germany

Novartis Investigational Site, Augsburg D-86179, Germany

Novartis Investigational Site, Wolfsburg D-38440, Germany

Novartis Investigational Site, Rostock D-18055, Germany

University of Alabama at Birmingham, Birmingham, Alabama 35294, United States

Novartis Investigational Site, Edmonton, Alberta T6G 2B6, Canada

Quality of Life Medical & Research Center, LLC, Tucson, Arizona 85712, United States

Chandler, Arizona 85225, United States

Women's Health Research, Phoenix, Arizona 85015, United States

The Woman's Clinic, Little Rock, Arkansas 72205, United States

NEA Women's Clinic, Jonesboro, Arkansas 72401, United States

Burke Pharmaceutical Research, Hot Springs, Arkansas 71913, United States

Novartis Investigational Site, Vancouver, British Columbia V6Z 2C7, Canada

Sacramento Research Medical Group, Sacramento, California 95825, United States

North California Research Corp., Sacramento, California 95831, United States

Providence Clinical Research, Burbank, California 91505, United States

Medical Center for Clinical Research, San Diego, California 92108, United States

Dermatology Research Associates, Los Angeles, California 90045, United States

Cohen & Womack, P.C., Lakewood, Colorado 80228, United States

Barbara Davis Center, Denver, Colorado 80262, United States

Visions Clinical Research, Boynton Beach, Florida 33437, United States

Palm Beach Research Center, West Palm Beach, Florida 33409, United States

Avancia Research, Pembroke Pines, Florida 33024, United States

Women's Medical Research Group, LLC, Clearwater, Florida 33759, United States

University Clinical Research, Inc., Pembroke Pines, Florida 33024, United States

Orlando Clinical Research Ctr., Orlando, Florida 32809, United States

International Research Association LLC, Miami, Florida 33156, 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

Novartis Investigational Site, Winnipeg, Manitoba R3E 0W3, Canada

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

Hawthorne Medical Research, Inc., Winston-Salem, North Carolina 27103, United States

UNC Clinical Research., Raleigh, North Carolina 27607, United States

Providence Health Partners-Center for Clinical Research, Dayton, Ohio 45439, United States

Lynne Health Science Institute, Oklahoma City, Oklahoma 73112, United States

Novartis Investigational Site, Ottawa, Ontario K1S 0G8, Canada

Novartis Investigational Site, Markham, Ontario L3P 1A8, Canada

Westover Heights Clinic, Portland, Oregon 97210, United States

Magee Womens Hospital, Pittsburgh, Pennsylvania 15213, United States

Paddington Testing Co. Inc, Philadelphia, Pennsylvania 19103, United States

Novartis Investigational Site, Montréal, Quebec H3H IV4, Canada

Novartis Investigational Site, Laval, Quebec H7X 3S5, Canada

Novartis Investigational Site, Montréal, Quebec H2K 4L5, Canada

Novartis Investigational Site, Sainte-Foy, Quebec G1V 4G2, Canada

Palmetto Clinical Trial Services, LLC, Simpsonville, South Carolina 29681, United States

S. Carolina Clinical Research Center, Columbia, South Carolina 29201, United States

Research Inc., Florence, South Carolina 29501, United States

Center for Clinical Studies, Houston, Texas 77058, United States

Center for Clinical Studies (TX Medical Center), Houston, Texas 77030, United States

Renaissance Clinical Research and Hypertension Clinic, Dallas, Texas 75235, United States

Benchmark Research, Austin, Texas 78705, United States

Salt Lake Women's Center/Physician's Research Options, Sandy, Utah 84070, United States

University of Utah-School of Medicine (Div. of Inf. Disease), Salt Lake City, Utah 84132, United States

Clinical Trials of Virginia, Inc., Richmond, Virginia 23225, United States

Liberty Research Center, Tacoma, Washington 98405, United States

University of Washington, Virology Research Clinic, Seattle, Washington 98122, United States

eRecruitment

Starting date: March 2006
Last updated: February 20, 2008