Clinical trial NCT00306787: Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Genital Herpes
Keywords: Herpes simplex
genital herpes
famciclovir
valacyclovir
Recurrent genital herpes
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-03-24
Enrollment: 1179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions
timeFrame: 72 hours after initiation of study medication up to Day 20
Secondary outcomes:
measure: Percentage of Participants With Aborted Genital Herpes Lesions
timeFrame: 72 hours after initiation of study medication up to Day 20
measure: Investigator-assessed Time to Healing of All (Non-aborted and Aborted) Genital Herpes Lesions
timeFrame: 72 hours after initiation of study medication up to Day 20
measure: Time to Resolution of Symptoms Associated With Recurrent Genital Herpes
timeFrame: 72 hours after initiation of study medication up to Day 20
measure: Number of Patients With a Second Recurrence of Genital Herpes
timeFrame: Up to 6 months after investigator assessed healing of first recurrence of genital herpes
measure: Time to a Second Recurrence of Genital Herpes
timeFrame: Up to 6 months after investigator assessed healing of first recurrence of genital herpes
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Chandler
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Phoenix
country: United States
facility: Women's Health Research
state: Arizona
city: Tucson
country: United States
facility: Quality of Life Medical & Research Center, LLC
state: Arizona
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Jonesboro
country: United States
facility: NEA Women's Clinic
state: Arkansas
city: Little Rock
country: United States
facility: The Woman's Clinic
state: Arkansas
city: Burbank
country: United States
facility: Providence Clinical Research
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Sacramento
country: United States
facility: Sacramento Research Medical Group
state: California
city: Sacramento
country: United States
facility: North California Research Corp.
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: San Francisco
country: United States
facility: Conant Research
state: California
city: Denver
country: United States
facility: Barbara Davis Center
state: Colorado
city: Lakewood
country: United States
facility: Cohen & Womack, P.C.
state: Colorado
city: Boynton Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: Clearwater
country: United States
facility: Women's Medical Research Group, LLC
state: Florida
city: Miami
country: United States
facility: International Research Association LLC
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Ctr.
state: Florida
city: Pembroke Pines
country: United States
facility: Avancia Research
state: Florida
city: Pembroke Pines
country: United States
facility: University Clinical Research, Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Atlanta
country: United States
facility: Mount Vernon Clinical Research
state: Georgia
city: Evansville
country: United States
facility: Medisphere Medical Research Center, LLC.
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Infectious Disease Research Group
state: Indiana
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Madisonville
country: United States
facility: Common Wealth Biomedical Research
state: Kentucky
city: Baltimore
country: United States
facility: SNBL Clinical Pharmacology Center
state: Maryland
city: Springfield
country: United States
facility: Future Care Studies
state: Massachusetts
city: St. Louis
country: United States
facility: Clayton Research Institute
state: Missouri
city: Billings
country: United States
facility: Deaconess Billings Clinic Research Center
state: Montana
city: Omaha
country: United States
facility: Heartland Clinical Research, Inc.
state: Nebraska
city: Raleigh
country: United States
facility: UNC Clinical Research.
state: North Carolina
city: Winston-Salem
country: United States
facility: Hawthorne Medical Research, Inc.
state: North Carolina
city: Dayton
country: United States
facility: Providence Health Partners-Center for Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Lynne Health Science Institute
state: Oklahoma
city: Portland
country: United States
facility: Westover Heights Clinic
state: Oregon
city: Philadelphia
country: United States
facility: Paddington Testing Co. Inc
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee Womens Hospital
state: Pennsylvania
city: Columbia
country: United States
facility: S. Carolina Clinical Research Center
state: South Carolina
city: Florence
country: United States
facility: Research Inc.
state: South Carolina
city: Simpsonville
country: United States
facility: Palmetto Clinical Trial Services, LLC
state: South Carolina
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: Dallas
country: United States
facility: Renaissance Clinical Research and Hypertension Clinic
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies (TX Medical Center)
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah-School of Medicine (Div. of Inf. Disease)
state: Utah
city: Sandy
country: United States
facility: Salt Lake Women's Center/Physician's Research Options
state: Utah
city: Richmond
country: United States
facility: Clinical Trials of Virginia, Inc.
state: Virginia
city: Seattle
country: United States
facility: University of Washington, Virology Research Clinic
state: Washington
city: Tacoma
country: United States
facility: Liberty Research Center
state: Washington
city: Darlinghurst
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Edmonton
country: Canada
facility: Novartis Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: Novartis Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Novartis Investigational Site
state: Manitoba
city: Markham
country: Canada
facility: Novartis Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Novartis Investigational Site
state: Ontario
city: Laval
country: Canada
facility: Novartis Investigational Site
state: Quebec
city: Montréal
country: Canada
facility: Novartis Investigational Site
state: Quebec
city: Montréal
country: Canada
facility: Novartis Investigational Site
state: Quebec
city: Sainte-Foy
country: Canada
facility: Novartis Investigational Site
state: Quebec
city: Augsburg
country: Germany
facility: Novartis Investigational Site
city: Berlin
country: Germany
facility: Novartis Investigational Site
city: Freiburg
country: Germany
facility: Novartis Investigational Site
city: Rostock
country: Germany
facility: Novartis Investigational Site
city: Wolfsburg
country: Germany
facility: Novartis Investigational Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.