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

Genital Herpes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00306787
• Other study ID #: CFAM810A2308
• Status: Completed
• Phase: Phase 3
• First received: March 22, 2006
• Last updated: June 28, 2011
• Start date: March 2006
• Est. completion date: February 2008

Study information

• Verified date: June 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesCanada: Health CanadaAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1179
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Genital Herpes
• Herpes Genitalis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Darlinghurst	New South Wales
Canada	Novartis Investigational Site	Edmonton	Alberta
Canada	Novartis Investigational Site	Laval	Quebec
Canada	Novartis Investigational Site	Markham	Ontario
Canada	Novartis Investigational Site	Montréal	Quebec
Canada	Novartis Investigational Site	Montréal	Quebec
Canada	Novartis Investigational Site	Ottawa	Ontario
Canada	Novartis Investigational Site	Sainte-Foy	Quebec
Canada	Novartis Investigational Site	Vancouver	British Columbia
Canada	Novartis Investigational Site	Winnipeg	Manitoba
Germany	Novartis Investigational Site	Augsburg
Germany	Novartis Investigational Site	Berlin
Germany	Novartis Investigational Site	Freiburg
Germany	Novartis Investigational Site	Rostock
Germany	Novartis Investigational Site	Wolfsburg
United States	Mount Vernon Clinical Research	Atlanta	Georgia
United States	Benchmark Research	Austin	Texas
United States	SNBL Clinical Pharmacology Center	Baltimore	Maryland
United States	Deaconess Billings Clinic Research Center	Billings	Montana
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Visions Clinical Research	Boynton Beach	Florida
United States	Providence Clinical Research	Burbank	California
United States	Novartis Investigative Site	Chandler	Arizona
United States	Women's Medical Research Group, LLC	Clearwater	Florida
United States	S. Carolina Clinical Research Center	Columbia	South Carolina
United States	Renaissance Clinical Research and Hypertension Clinic	Dallas	Texas
United States	Providence Health Partners-Center for Clinical Research	Dayton	Ohio
United States	Barbara Davis Center	Denver	Colorado
United States	Medisphere Medical Research Center, LLC.	Evansville	Indiana
United States	Research Inc.	Florence	South Carolina
United States	Burke Pharmaceutical Research	Hot Springs	Arkansas
United States	Center for Clinical Studies	Houston	Texas
United States	Center for Clinical Studies (TX Medical Center)	Houston	Texas
United States	Indiana University Infectious Disease Research Group	Indianapolis	Indiana
United States	NEA Women's Clinic	Jonesboro	Arkansas
United States	Cohen & Womack, P.C.	Lakewood	Colorado
United States	The Woman's Clinic	Little Rock	Arkansas
United States	Dermatology Research Associates	Los Angeles	California
United States	Common Wealth Biomedical Research	Madisonville	Kentucky
United States	International Research Association LLC	Miami	Florida
United States	Lynne Health Science Institute	Oklahoma City	Oklahoma
United States	Heartland Clinical Research, Inc.	Omaha	Nebraska
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	Paddington Testing Co. Inc	Philadelphia	Pennsylvania
United States	Women's Health Research	Phoenix	Arizona
United States	Magee Womens Hospital	Pittsburgh	Pennsylvania
United States	Westover Heights Clinic	Portland	Oregon
United States	UNC Clinical Research.	Raleigh	North Carolina
United States	Clinical Trials of Virginia, Inc.	Richmond	Virginia
United States	North California Research Corp.	Sacramento	California
United States	Sacramento Research Medical Group	Sacramento	California
United States	University of Utah-School of Medicine (Div. of Inf. Disease)	Salt Lake City	Utah
United States	Medical Center for Clinical Research	San Diego	California
United States	Conant Research	San Francisco	California
United States	Salt Lake Women's Center/Physician's Research Options	Sandy	Utah
United States	University of Washington, Virology Research Clinic	Seattle	Washington
United States	Palmetto Clinical Trial Services, LLC	Simpsonville	South Carolina
United States	Future Care Studies	Springfield	Massachusetts
United States	Clayton Research Institute	St. Louis	Missouri
United States	Liberty Research Center	Tacoma	Washington
United States	Quality of Life Medical & Research Center, LLC	Tucson	Arizona
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	Heartland Research Associates, LLC	Wichita	Kansas
United States	Hawthorne Medical Research, Inc.	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percentage of Participants With Aborted Genital Herpes Lesions	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.	72 hours after initiation of study medication up to Day 20	No
Secondary	Investigator-assessed Time to Healing of All (Non-aborted and Aborted) Genital Herpes Lesions	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.	72 hours after initiation of study medication up to Day 20	No
Secondary	Time to Resolution of Symptoms Associated With Recurrent Genital Herpes	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.	72 hours after initiation of study medication up to Day 20	No
Secondary	Number of Patients With a Second Recurrence of Genital Herpes	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.	Up to 6 months after investigator assessed healing of first recurrence of genital herpes	No
Secondary	Time to a Second Recurrence of Genital Herpes	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: From the date of treatment initiation no earlier than the recurrence of genital herpes to the date of onset for the second recurrence, or; From the date of healing of non-aborted lesions or confirmation of aborted lesions to the date of onset for the second recurrence.	Up to 6 months after investigator assessed healing of first recurrence of genital herpes	No