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

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00116844

First received: June 30, 2005

Last updated: March 17, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

June 30, 2005

Last Updated Date

March 17, 2011

Start Date ^ICMJE

March 2005

Primary Completion Date

January 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Effect of valacyclovir 1g once daily for 60 days on HSV-2 viral shedding

Change History

Complete list of historical versions of study NCT00116844 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Safety of valacyclovir 1g once daily for 60 days in healthy subjects with no previous history of symptomatic genital herpes infection

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Genital Herpes
Infections, Herpesviridae

Intervention ^ICMJE

Drug: Valaciclovir

Valtrex 1g QD

Other Name: Valaciclovir

Study Arm (s)

Placebo Comparator: Placebo
Val vs Placebo

Intervention: Drug: Valaciclovir
Active Comparator: 1g QD
Valtrex

Intervention: Drug: Valaciclovir

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2006

Primary Completion Date

January 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00116844

Other Study ID Numbers ^ICMJE

VLX103596

Has Data Monitoring Committee

Responsible Party

Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

March 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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