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

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 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding

Resource links provided by NLM:

MedlinePlus related topics: Genital Herpes

Drug Information available for: Famciclovir

U.S. FDA Resources

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
Study Completion Date:	October 2005
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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: 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	Novartis Pharmaceuticals

More Information


ClinicalTrials.gov Identifier:	NCT00129818 History of Changes
Other Study ID Numbers:	CFAM810A2404
Study First Received:	August 11, 2005
Last Updated:	April 26, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:


Genital herpes viral shedding famciclovir Symptomatic genital herpes Asymptomatic 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 2-Aminopurine Antiviral Agents Anti-Infective Agents Antimetabolites Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2016