A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00129818

Purpose

The study is designed to assess the efficacy and safety of famciclovir 250 mg twice a day (bid) suppressive treatment in men and women with herpes virus type 2 (HSV-2) infection, with and without a reported history of genital herpes and with or without herpes virus type 1 (HSV-1) seropositivity.

Condition	Intervention	Phase
Genital Herpes	Drug: Famciclovir	Phase IV

Drug Information available for: Famciclovir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding

Further study details as provided by Novartis:

Primary Outcome Measures:

Group 1. Reduction of HSV DNA PCR positive days in HSV-2 seropositive patients with a history of clinical genital herpes lesions
Group 2. Reduction of HSV DNA PCR positive days in HSV-2 seropositive patients without a history of clinical genital herpes lesions

Secondary Outcome Measures:

reduction of HSV DNA PCR positive days without lesions in HSV-2 seropositive patients with and without a history of clinical genital herpes lesions
quantitative HSV DNA PCR, during the days with positive HSV-2 shedding.
time to the first recurrence of genital herpes and number of genital herpes recurrence episodes
oral HSV-1 and/or HSV-2 shedding in HSV-1 and HSV-2 seropositive patients
reduction of HSV DNA PCR positive days with lesions in HSV-2 seropositive patients with and without a history of clinical genital herpes lesions

Study Start Date:

July 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Males or non-pregnant females at least 18 years of age with HSV-2 seropositive serology with or without history of clinically diagnosed recurrent genital herpes

Exclusion Criteria:

Pregnancy
History of renal dysfunction
Use of immunosuppressive therapy, including steroids (other than topical or inhaled), or use of probenecid
Hypersensitivity to famciclovir, valacyclovir or drugs with similar chemical structure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129818

Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Florida
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
United States, Indiana
IU Center for Clinical STD Research
Indianapolis, Indiana, United States, 46202
United States, North Carolina
UNC Clinical Research - Raleigh
Raleigh, North Carolina, United States, 27607
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, Washington
University of Washington - Virology Research Clinic
Seattle, Washington, United States, 98122

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharmaceuticals

More Information

Study ID Numbers:	CFAM810A2404
Study First Received:	August 11, 2005
Last Updated:	August 23, 2006
ClinicalTrials.gov Identifier:	NCT00129818
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Genital herpes
viral shedding
famciclovir
Symptomatic genital herpes
Asymptomatic genital herpes

Study placed in the following topic categories:

Genital Diseases, Female
Herpes Simplex
Virus Diseases
Sexually Transmitted Diseases, Viral
Famciclovir

Herpes Genitalis
Sexually Transmitted Diseases
DNA Virus Infections
Genital Diseases, Male
Herpesviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009