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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
June 30, 2005
December 21, 2016
March 2005
January 2006   (Final data collection date for primary outcome measure)
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.
Effect of valacyclovir 1g once daily for 60 days on HSV-2 viral shedding
Complete list of historical versions of study NCT00116844 on ClinicalTrials.gov Archive Site
  • 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.
Safety of valacyclovir 1g once daily for 60 days in healthy subjects with no previous history of symptomatic genital herpes infection
Not Provided
Not Provided
 
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.
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.
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Infections, Herpesviridae
Drug: Valaciclovir
Valtrex 1g QD
  • Placebo Comparator: Placebo
    Val vs Placebo
    Intervention: Drug: Valaciclovir
  • Active Comparator: 1g QD
    Valtrex
    Intervention: Drug: Valaciclovir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
January 2006
January 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00116844
VLX103596
No
Not Provided
Yes
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
December 2016

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