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.

Overview

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.

Full Title of Study: “Valacyclovir for the Suppression of HSV-2 Viral Shedding in HSV-2 Seropositive Individuals With No History of Symptomatic GH”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 10, 2006

Interventions

  • Drug: Valaciclovir
    • Valtrex 1g once daily
  • Drug: Placebo
    • placebo

Arms, Groups and Cohorts

  • Experimental: Sequence 1: VALTREX 1 g once daily, Placebo
    • VALTREX 1 g once daily, Placebo
  • Experimental: Sequence 2: Placebo, VALTREX 1 g once daily
    • Placebo, VALTREX 1 g once daily

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary 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 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.

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GSK Clinical Trials, Study Director, GlaxoSmithKline

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