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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.

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ClinicalTrials.gov Identifier: NCT00116844
Recruitment Status : Completed
First Posted : July 1, 2005
Results First Posted : February 12, 2018
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

June 30, 2005
July 1, 2005
March 16, 2017
February 12, 2018
February 12, 2018
March 29, 2005
January 10, 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 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, 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 was classified as 'clinical' (presence of genital lesions) or subclinical (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 was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions). The total shedding rate was defined for each participant as the percentage 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 number of participants with no shedding was defined as the number of participants with no HSV-2 shedding detected by PCR divided by the total number of participants with PCR data. During each 60-day treatment period and during washout, swabs were collected daily from the genital/anal-rectal area for HSV-2 detection by PCR. During an outbreak, lesion swabs were also collected for HSV-2 detection by PCR. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions).
  • 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) ]
    The subclinical shedding rate was defined for each participant as the total number of subclinical days on treatment during which shedding was detected by PCR. 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. During each 60-day treatment period and during washout, swabs were collected daily from the genital/anal-rectal area for HSV-2 detection by PCR. During an outbreak, lesion swabs were also collected for HSV-2 detection by PCR. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions).
  • 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) ]
    The total shedding rate was defined for each participant as the total number of all days (clinical and subclinical) on treatment during which shedding was detected by PCR. 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 was log transformed and averaged over all shedding days. During each 60-day treatment period and during washout, swabs were collected daily from the genital/anal-rectal area for HSV-2 detection by PCR. During an outbreak, lesion swabs were also collected for HSV-2 detection by PCR. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions).
  • 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.
Valacyclovir for the Suppression of HSV-2 Viral Shedding in HSV-2 Seropositive Individuals With No History of Symptomatic GH
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 (Participant, Investigator)
Primary Purpose: Treatment
Infections, Herpesviridae
  • Drug: Valaciclovir
    Valtrex 1g once daily
  • Drug: Placebo
    placebo
  • Experimental: Sequence 1: VALTREX 1 g once daily, Placebo
    VALTREX 1 g once daily, Placebo
    Interventions:
    • Drug: Valaciclovir
    • Drug: Placebo
  • Experimental: Sequence 2: Placebo, VALTREX 1 g once daily
    Placebo, VALTREX 1 g once daily
    Interventions:
    • Drug: Valaciclovir
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
65
January 10, 2006
January 10, 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, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00116844
VLX103596
No
Not Provided
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.
URL: http://
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2017

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