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
1 other identifier
interventional
73
1 country
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2005
Shorter than P25 for phase_4
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 29, 2005
CompletedFirst Submitted
Initial submission to the registry
June 30, 2005
CompletedFirst Posted
Study publicly available on registry
July 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2006
CompletedResults Posted
Study results publicly available
February 12, 2018
CompletedFebruary 12, 2018
August 1, 2017
10 months
June 30, 2005
March 16, 2017
August 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Percent Days of Subclinical Shedding as Determined by Type-specific Polymerase Chain Reaction (PCR) Assay for HSV-2
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.
Up to Day 60 of each treatment period (up to 160 days)
Secondary Outcomes (5)
Mean Percent Days of Total HSV-2 Shedding
Up to Day 60 of each treatment period (up to 160 days)
Number of Participants With no Shedding
Up to Day 60 of each treatment period (up to 160 days)
Mean Log HSV-2 DNA Copy Number Per Day on Days With Subclinical Shedding
Up to Day 60 of each treatment period (up to 160 days)
Mean Log HSV-2 DNA Copy Number Per Day on Days With Total Shedding
Up to Day 60 of each treatment period (up to 160 days)
Percent Overall Study Population Who Have Recognized Clinical Signs/Symptoms of Genital Herpes Infection During the Study
Up to Day 60 of each treatment period (up to 160 days)
Study Arms (2)
Sequence 1: VALTREX 1 g once daily, Placebo
EXPERIMENTALVALTREX 1 g once daily, Placebo
Sequence 2: Placebo, VALTREX 1 g once daily
EXPERIMENTALPlacebo, VALTREX 1 g once daily
Interventions
Valtrex 1g once daily
placebo
Eligibility Criteria
You may qualify if:
- In overall general good health.
- HSV-2 (Herpes Simplex Virus-2) seropositive at screening.
You may not qualify if:
- have active lesions consistent with genital herpes.
- previous history of symptomatic genital herpes.
- history of recurrent, undiagnosed symptoms consistent with genital herpes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (17)
GSK Investigational Site
Carmichael, California, 95608, United States
GSK Investigational Site
Davis, California, 95616, United States
GSK Investigational Site
Riverside, California, 92506, United States
GSK Investigational Site
Sacramento, California, 92585, United States
GSK Investigational Site
Fort Wayne, Indiana, 46804, United States
GSK Investigational Site
Indianapolis, Indiana, 46202, United States
GSK Investigational Site
Boston, Massachusetts, 02115, United States
GSK Investigational Site
New York, New York, 10011, United States
GSK Investigational Site
New York, New York, 10029, United States
GSK Investigational Site
Stony Brook, New York, 11794, United States
GSK Investigational Site
The Bronx, New York, 10461, United States
GSK Investigational Site
Chapel Hill, North Carolina, 27599, United States
GSK Investigational Site
Tulsa, Oklahoma, 74104, United States
GSK Investigational Site
Portland, Oregon, 97210, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Salt Lake City, Utah, 84132, United States
GSK Investigational Site
Seattle, Washington, 98104, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2005
First Posted
July 1, 2005
Study Start
March 29, 2005
Primary Completion
January 10, 2006
Study Completion
January 10, 2006
Last Updated
February 12, 2018
Results First Posted
February 12, 2018
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.