VALTREX Once Daily For Viral Shedding In Herpes Simplex Virus 2 (HSV-2) Seropositive Subjects. VALTREX® Tablet is a Trademark of GlaxoSmithKline Group of Companies.

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-29

Study Completion Date

2006-01-10

Brief Summary

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Eligible subjects will be randomized to receive VALTREX® tablet 1g or placebo once daily for 60 days in a two-way crossover study with a washout period of 7 days between treatment periods.

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Detailed Description

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Conditions

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Infections, Herpesviridae

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sequence 1: VALTREX 1 g once daily, Placebo

VALTREX 1 g once daily, Placebo

Group Type EXPERIMENTAL

Valaciclovir

Intervention Type DRUG

Valtrex 1g once daily

Placebo

Intervention Type DRUG

placebo

Sequence 2: Placebo, VALTREX 1 g once daily

Placebo, VALTREX 1 g once daily

Group Type EXPERIMENTAL

Valaciclovir

Intervention Type DRUG

Valtrex 1g once daily

Placebo

Intervention Type DRUG

placebo

Interventions

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Valaciclovir

Valtrex 1g once daily

Intervention Type DRUG

Placebo

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* In overall general good health.
* HSV-2 (Herpes Simplex Virus-2) seropositive at screening.

Exclusion Criteria

* have active lesions consistent with genital herpes.
* previous history of symptomatic genital herpes.
* history of recurrent, undiagnosed symptoms consistent with genital herpes.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Carmichael, California, United States

Site Status

GSK Investigational Site

Davis, California, United States

Site Status

GSK Investigational Site

Riverside, California, United States

Site Status

GSK Investigational Site

Sacramento, California, United States

Site Status

GSK Investigational Site

Fort Wayne, Indiana, United States

Site Status

GSK Investigational Site

Indianapolis, Indiana, United States

Site Status

GSK Investigational Site

Boston, Massachusetts, United States

Site Status

GSK Investigational Site

New York, New York, United States

Site Status

GSK Investigational Site

New York, New York, United States

Site Status

GSK Investigational Site

Stony Brook, New York, United States

Site Status

GSK Investigational Site

The Bronx, New York, United States

Site Status

GSK Investigational Site

Chapel Hill, North Carolina, United States

Site Status

GSK Investigational Site

Tulsa, Oklahoma, United States

Site Status

GSK Investigational Site

Portland, Oregon, United States

Site Status

GSK Investigational Site

Houston, Texas, United States

Site Status

GSK Investigational Site

Salt Lake City, Utah, United States

Site Status

GSK Investigational Site

Seattle, Washington, United States

Site Status

Countries

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United States

Study Documents

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