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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.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00116844
First received: June 30, 2005
Last updated: December 21, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention Phase
Infections, Herpesviridae
Drug: Valaciclovir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, 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:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Mean percent days of subclinical shedding as determined by type-specific Polymerase Chain Reaction (PCR) assay for Herpes Simplex Virus Type 2 (HSV-2) [ Time Frame: Up to Day 60 of each treatment period (up to 160 days) ]
    Percent of subclinical days with HSV-2 shedding was defined for each participant as the percent of subclinical days with PCR data for which HSV-2 shedding was detected by a positive PCR result, that is (i.e.), the number of subclinical days with HSV-2 PCR shedding divided by total number of subclinical days with PCR data, multiplied by 100. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day will be classified as 'clinical' (i.e., presence of genital lesions) or 'subclinical" (i.e., no genital lesions). Genital/anal-rectal swabs was collected daily during each entire 60-day treatment period of each period and the washout period.


Secondary Outcome Measures:
  • Mean percent days of total HSV-2 shedding [ Time Frame: Up to Day 60 of each treatment period (up to 160 days) ]
    The percent of days with total (clinical and subclinical) HSV-2 shedding was defined as the percent of all days with PCR data for which HSV-2 shedding was detected. Mean percent of days with total HSV-2 shedding was the statistic used to summarize this endpoint for each treatment group. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day will be classified as 'clinical' (i.e., presence of genital lesions) or 'subclinical" (i.e., no genital lesions). The total shedding rate is defined for each participant as the proportion of all days (clinical and subclinical) on treatment during which shedding was detected by PCR. Genital/anal-rectal swabs was collected daily during each entire 60-day treatment period of each period and the washout period.

  • Number of participants with no shedding [ Time Frame: Up to Day 60 of each treatment period (up to 160 days) ]
    The proportion of participants with no shedding is defined as the number of participants with no HSV-2 shedding detected by PCR divided by the total number of participants with PCR data.

  • Mean log HSV-2 DNA copy number per day on days with subclinical shedding [ Time Frame: Up to Day 60 of each treatment period (up to 160 days) ]
    Average log HSV-2 DNA copy number per day on days with subclinical shedding was defined as the daily maximum HSV-2 DNA copy number was log transformed and averaged over all subclinical shedding days.

  • Mean log HSV-2 DNA copy number per day on days with total shedding [ Time Frame: Up to Day 60 of each treatment period (up to 160 days) ]
    Average log HSV-2 DNA copy number per day on days with total shedding (clinical and subclinical) was defined as the daily maximum HSV-2 DNA copy number will be log transformed and averaged over all shedding days.

  • Percent overall study population who have recognized clinical signs/symptoms of genital herpes infection during the study [ Time Frame: Up to Day 60 of each treatment period (up to 160 days) ]
    Participants who have recognized clinical signs/symptoms of genital herpes infection during the study. Participants were educated on recognizing signs and symptoms of genital herpes infection at the screening/randomization visit. Genital examinations was conducted at the randomization and genital herpes outbreak visits.


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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Bronx, New York, United States, 10461
GSK Investigational Site
New York, New York, United States, 10011
GSK Investigational Site
New York, New York, United States, 10029
GSK Investigational Site
Stony Brook, New York, United States, 11794
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

Additional Information:
Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: VLX103596
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: VLX103596
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: VLX103596
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: VLX103596
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: VLX103596
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: VLX103596
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: VLX103596
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00116844     History of Changes
Obsolete Identifiers: NCT00268190
Other Study ID Numbers: VLX103596
Study First Received: June 30, 2005
Last Updated: December 21, 2016
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
viral shedding
Recurrent
herpes
genital herpes

Additional relevant MeSH terms:
Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Valacyclovir
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 23, 2017