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

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ClinicalTrials.gov Identifier: NCT00129818

Recruitment Status : Completed

First Posted : August 12, 2005

Last Update Posted : April 27, 2012

Sponsor:

Information provided by:

Novartis

Study Description

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genital Herpes

Drug Information available for: Famciclovir

U.S. FDA Resources

Arms and Interventions

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00129818

Locations

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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

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Study Chair:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

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ClinicalTrials.gov Identifier:	NCT00129818 History of Changes
Other Study ID Numbers:	CFAM810A2404
First Posted:	August 12, 2005 Key Record Dates
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:

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Herpes Genitalis Herpesviridae Infections DNA Virus Infections Virus Diseases Herpes Simplex Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Genital Diseases, Male	Genital Diseases, Female Famciclovir Antiviral Agents Anti-Infective Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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