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

NCT ID: NCT00129818

Last Updated: 2012-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2005-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Genital Herpes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Famciclovir

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_CHAIR

Novartis Pharmaceuticals

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Orlando Clinical Research Center

Orlando, Florida, United States

Site Status

IU Center for Clinical STD Research

Indianapolis, Indiana, United States

Site Status

UNC Clinical Research - Raleigh

Raleigh, North Carolina, United States

Site Status

Lynne Health Science Institute

Oklahoma City, Oklahoma, United States

Site Status

Westover Heights Clinic

Portland, Oregon, United States

Site Status

University of Washington - Virology Research Clinic

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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CFAM810A2404

Identifier Type: -

Identifier Source: org_study_id

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