VALTREX(Valacyclovir) Once Daily for Viral Shedding In Subjects Newly Diagnosed With HSV-2

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00306293
First received: March 21, 2006
Last updated: May 31, 2012
Last verified: March 2011
  Purpose

Eligible subjects will be randomized to receive VALTREX 1g or placebo once daily for 60 days in a two-way crossover study with a washout period of 7 days in between.


Condition Intervention Phase
Genital Herpes
Herpes Labialis
Drug: valacyclovir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effect of Valacyclovir 1g Once Daily on HSV-2 Viral Shedding in Subjects Newly Diagnosed With Genital Herpes Infection

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Effect of VALTREX administered once daily for 60 days versus placebo on total HSV-2 shedding in immunocompetent subjects newly diagnosed with HSV-2 infection. [ Time Frame: 60 days ]

Secondary Outcome Measures:
  • Safety of VALTREX 1g administered once daily for 60 days in immunocompetent HSV-2 seropositive subjects newly diagnosed with HSV-2 infection. [ Time Frame: 60 days ]

Estimated Enrollment: 66
Study Start Date: February 2006
Intervention Details:
    Drug: valacyclovir
    Other Name: valacyclovir
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is in overall general good health.
  • If female, subject must be of:

    1. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal or surgically sterile); or
    2. Childbearing potential, but must have a negative pregnancy test at randomization, and must be compliant with one of the following: Complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period of 1 week after study completion or premature discontinuation from the study (to account for elimination of the drug); Have a male partner who is confirmed to be sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject; Use of contraceptive(s) with a documented failure rate of less than 1% per year, including but not limited to: implants of levonorgestrel, use of injectable progestogen, oral contraceptives (either combined or progestogen only), an intrauterine device (IUD) or spermicide plus a mechanical barrier (condom/diaphragm).
  • Subjects must be newly diagnosed with a first recognized episode of genital herpes as described in (a) or (b) below (See Appendix 3): a.HSV-2 seropositive at screen, with documented clinical signs and symptoms consistent with genital herpes at screen or within 4 months prior to randomization or b.HSV-2 seronegative at screen, AND HSV-2 culture positive or HSV-2 PCR positive with documented clinical signs and symptoms consistent with genital herpes at screen or within 4 months prior to randomization.
  • Subject must be willing and able to provide written informed consent and comply with the protocol.

Exclusion Criteria:

  • Subject is known or suspected to be immunocompromised (e.g., subjects receiving immunosuppressive therapy or chemotherapy for malignancy, or are seropositive for HIV).
  • Subject received an investigational drug in the 30 days prior to the randomization visit.
  • Subject is receiving systemic antiviral or immunomodulatory treatments.
  • Subjects who have received systemic antiherpetic treatments (e.g., valacyclovir, acyclovir, ganciclovir, famciclovir) within 3 days of starting study drug, or immunomodulatory treatments in the 30 days before starting study drug.
  • Subject has clinically significantly impaired renal function as defined by creatinine clearance less than 50ml/min (calculated using the Cockcroft-Gault formula).
  • Subjects with a history or evidence of decompensated liver disease, or clinically significantly impaired hepatic function defined as an ALT (alanine transaminase) level >3 times the normal upper limit.
  • Subject is known to be hypersensitive to valacyclovir, acyclovir, ganciclovir or famciclovir.
  • Subject has malabsorption or vomiting syndrome or other gastrointestinal dysfunction that may impair drug pharmacokinetics.
  • Female subject who is contemplating pregnancy within the duration of the study drug dosing period.
  • Female subject who is pregnant and/or nursing.
  • Subject with current alcohol or drug abuse.
  • Subjects who have received suppressive (daily) therapy for genital herpes prior to randomization. Suppressive therapy is defined as daily antiherpetic therapy of at least 4 weeks duration.
  • Subjects with a history of ocular HSV (herpes simplex virus) infection.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00306293

Locations
United States, California
GSK Investigational Site
Anaheim, California, United States, 92805
GSK Investigational Site
Fair Oaks, California, United States, 95628
GSK Investigational Site
Sacramento, California, United States, 95816
GSK Investigational Site
San Diego, California, United States, 92123
United States, Florida
GSK Investigational Site
Boynton Beach, Florida, United States, 33437
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
GSK Investigational Site
South Bend, Indiana, United States, 46601
United States, Michigan
GSK Investigational Site
Portage, Michigan, United States, 49024
United States, New York
GSK Investigational Site
New York, New York, United States, 10029
United States, North Carolina
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Oklahoma
GSK Investigational Site
Tulsa, Oklahoma, United States, 74104
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97210
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
United States, Tennessee
GSK Investigational Site
Memphis, Tennessee, United States, 38120
GSK Investigational Site
Memphis, Tennessee, United States, 38104
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00306293     History of Changes
Other Study ID Numbers: VLX105832
Study First Received: March 21, 2006
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Recurrent Genital Herpes

Additional relevant MeSH terms:
Herpes Genitalis
Herpes Labialis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Skin Diseases, Viral
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Skin Diseases, Infectious
Skin Diseases
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014