A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Genital Herpes	Drug: Famciclovir	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding
Study Start Date :	July 2004
Actual Primary Completion Date :	October 2005
Actual Study Completion Date :	October 2005

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Group 1. Reduction of HSV DNA PCR positive days in HSV-2 seropositive patients with a history of clinical genital herpes lesions
2. 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 :

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

Eligibility Criteria

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

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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00129818 History of Changes
Other Study ID Numbers:	CFAM810A2404
First Posted:	August 12, 2005
Last Update Posted:	April 27, 2012
Last Verified:	April 2012

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