VALTREX(Valacyclovir) Once Daily for Viral Shedding In Subjects Newly Diagnosed With HSV-2

Part of paid clinical trials in Anaheim, California.

Sponsor
GlaxoSmithKline
Study ID
NCT00306293
Phase
PHASE4
Status
Completed

Conditions

  • Herpes Labialis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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 in between.

Key Dates

Start date
Feb 20, 2006
Status verified
Aug 2017
Primary completion
Nov 27, 2006
Completion
Nov 27, 2006

Study Design

Enrollment
70 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Primary Outcome Measure

Mean Percent Days of Total Shedding (Clinical and Subclinical) as Determined by Type-specific Polymerase Chain Reaction (PCR) Assay for Herpes Simplex Virus Type 2 (HSV-2) [ Time Frame: Up to 60 days in each treatment period (Up to 148 days) ]

Locations (18)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteAnaheimCalifornia92805-
GSK Investigational SiteCarmichaelCalifornia95608-
GSK Investigational SiteFair OaksCalifornia95628-
GSK Investigational SiteSacramentoCalifornia95816-
GSK Investigational SiteSan DiegoCalifornia92123-
GSK Investigational SiteBoynton BeachFlorida33437-
GSK Investigational SiteSt. PetersburgFlorida33710-
GSK Investigational SiteIndianapolisIndiana46202-
GSK Investigational SiteSouth BendIndiana46601-
GSK Investigational SitePortageMichigan49024-
GSK Investigational SiteNew YorkNew York10029-
GSK Investigational SiteChapel HillNorth Carolina27599-
GSK Investigational SiteWinston-SalemNorth Carolina27103-
GSK Investigational SiteTulsaOklahoma74104-
GSK Investigational SitePortlandOregon97210-
GSK Investigational SitePhiladelphiaPennsylvania19140-
GSK Investigational SiteMemphisTennessee38104-
GSK Investigational SiteMemphisTennessee38120-

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By research site
GSK Investigational Site· Anaheim, CAGSK Investigational Site· Carmichael, CAGSK Investigational Site· Fair Oaks, CAGSK Investigational Site· Sacramento, CAGSK Investigational Site· San Diego, CAGSK Investigational Site· Boynton Beach, FL

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