Last updated: 11/04/2018 13:35:28
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.
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Valacyclovir for the Suppression of HSV-2 Viral Shedding in HSV-2 Seropositive Individuals with No History of Symptomatic GH
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Mean percent days of subclinical shedding as determined by type-specific Polymerase Chain Reaction (PCR) assay for HSV-2
Timeframe: Up to Day 60 of each treatment period (up to 160 days)
Secondary outcomes:
Mean percent days of total HSV-2 shedding
Timeframe: Up to Day 60 of each treatment period (up to 160 days)
Number of participants with no shedding
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Up to Day 60 of each treatment period (up to 160 days)
Interventions:
Drug: Valaciclovir
Drug: Placebo
Enrollment:
73
Observational study model:
Not applicable
Primary completion date:
2006-03-01
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Infections, Herpesviridae
Product
valaciclovir
Collaborators
Not applicable
Study date(s)
March 2005 to January 2006
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- In overall general good health.
- HSV-2 (Herpes Simplex Virus-2) seropositive at screening.
- have active lesions consistent with genital herpes.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Bronx, New York, United States, 10461
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Seattle, Washington, United States, 98104
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02115
Status
Study Complete
Location
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
Status
Study Complete
Location
GSK Investigational Site
Fort Wayne, Indiana, United States, 46804
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97210
Status
Study Complete
Location
GSK Investigational Site
Stony Brook, New York, United States, 11794
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New York, New York, United States, 10011
Status
Study Complete
Location
GSK Investigational Site
Riverside, California, United States, 92506
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
Status
Study Complete
Location
GSK Investigational Site
Carmichael, California, United States, 95608
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 92585
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Davis, California, United States, 95616
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10029
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84132
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2006-03-01
Actual study completion date
2006-03-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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