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.

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GSK study ID
VLX103596
See study documents
Clinicaltrials.gov ID
NCT00116844
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2006-03-01
    Observational study model:
    Not applicable
    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
    • Inclusion Criteria:
    • In overall general good health.
    Inclusion and exclusion criteria
    Inclusion 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
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Bronx, New York, United States, 10461
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Seattle, Washington, United States, 98104
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Boston, Massachusetts, United States, 02115
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Chapel Hill, North Carolina, United States, 27599
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Tulsa, Oklahoma, United States, 74104
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Fort Wayne, Indiana, United States, 46804
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 17 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    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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