VALTREX Once Daily For Viral Shedding In Herpes Simplex Virus 2 (HSV-2) Seropositive Subjects - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00116844

Purpose

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

Condition	Intervention	Phase
Genital Herpes Infections, Herpesviridae	Drug: Valaciclovir	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Two-Way Crossover Study to Investigate the Effect of VALTREX 1g Once Daily for 60 Days on Viral Shedding in HSV-2 Seropositive Subjects With No Previous History of Symptomatic Genital Herpes Infection.

Resource links provided by NLM:

MedlinePlus related topics: Genital Herpes Herpes Simplex

Drug Information available for: Valaciclovir Valacyclovir hydrochloride

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

To determine the effect of valaciclovir 1g once daily for 60 days on HSV-2 viral shedding. [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the safety of valaciclovir 1g once daily for 60 days in healthy subjects with no previous history of symptomatic genital herpes infection. [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Enrollment:	73
Study Start Date:	March 2005
Study Completion Date:	January 2006
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Val vs Placebo	Drug: Valaciclovir Valtrex 1g QD Other Name: Valaciclovir
Active Comparator: 1g QD Valtrex	Drug: Valaciclovir Valtrex 1g QD Other Name: Valaciclovir

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116844

Locations

United States, California
GSK Investigational Site
Carmichael, California, United States, 95608
GSK Investigational Site
Davis, California, United States, 95616
GSK Investigational Site
Riverside, California, United States, 92506
GSK Investigational Site
Sacramento, California, United States, 92585
United States, Indiana
GSK Investigational Site
Fort Wayne, Indiana, United States, 46804
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02115
United States, New York
GSK Investigational Site
New York, New York, United States, 10029
GSK Investigational Site
New York, New York, United States, 10011
United States, North Carolina
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
United States, Oklahoma
GSK Investigational Site
Tulsa, Oklahoma, United States, 74104
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97210
United States, Texas
GSK Investigational Site
Houston, Texas, United States, 77030
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84132
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98104

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00116844 History of Changes
Obsolete Identifiers:	NCT00268190
Other Study ID Numbers:	VLX103596
Study First Received:	June 30, 2005
Last Updated:	March 17, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

viral shedding
Recurrent
herpes
genital herpes

Additional relevant MeSH terms:

Herpes Genitalis
Herpesviridae Infections
Herpes Simplex
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases

Genital Diseases, Male
Genital Diseases, Female
Valacyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012