A Study Comparing Daily Treatment With Valaciclovir To Placebo For Suppression Of Herpes Simplex Virus HSV-2 Genital Herpes In Newly Diagnosed Patients

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00158860
First received: September 8, 2005
Last updated: May 10, 2013
Last verified: May 2013
  Purpose

Genital herpes (GH) is a commonly occurring sexually transmitted disease caused by herpes simplex virus (HSV). There are two types of HSV, type 1 (HSV-1) and type 2 (HSV-2); both can cause GH, although the latter is much more likely to produce frequent recurrences of GH lesions. Evidence suggests that there are advantages to using suppressive vs. episodic treatment, which include increased intervals between the pain and discomfort of genital herpes recurrences. Therefore, this study will collect safety and efficacy data on suppressive therapy with valaciclovir in subjects newly diagnosed with HSV-2 genital herpes.


Condition Intervention Phase
Genital Herpes
Herpes Genitalis
Drug: valaciclovir (Valtrex)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: An International, Randomized, Double-Blind, Placebo-Controlled, Multicenter, 6- Month Study of the Efficacy and Safety of Valaciclovir 1g Once Daily vs. Placebo for the Suppression of HSV-2 Genital Herpes in Newly Diagnosed Immunocompetent Subjects

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To determine the efficacy of administering valaciclovir 1 gram once daily for 6 months
  • vs. placebo for genital herpes suppressive therapy in immunocompetent newly diagnosed
  • subjects, the primary endpoint is time to first genital herpes recurrence

Secondary Outcome Measures:
  • Secondary measures include: adverse events, serious adverse events, etc.
  • Number of genital herpes recurrences within the study period
  • Time to first oral HSV outbreak
  • Collection of HSV-2 culture isolates to assess for resistance to acyclovir.

Enrollment: 315
Study Start Date: June 2004
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: valaciclovir (Valtrex)
    Other Name: valaciclovir (Valtrex)
  Eligibility

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

Inclusion criteria:

  • In overall general good health.
  • Females can enter and participate in this study if they are of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) or if of childbearing potential, has a negative pregnancy test (urine) at screening and agrees to use GSK stipulated contraceptive methods.
  • Must be newly diagnosed with a first recognized episode of GH at the time of the Screening Visit or within 3 months prior to the Screening Visit.

Exclusion criteria:

  • Known or suspected to be immunocompromised (e.g., subjects receiving immunosuppressive therapy or chemotherapy for malignancy, or are seropositive for HIV).
  • Received an investigational drug in the 30 days prior to the study.
  • Receiving systemic antiviral or immunomodulatory treatments.
  • Must not have received systemic antiviral treatments (e.g., valaciclovir, Famvir (famciclovir), acyclovir, lysine) within 3 days of starting study drug or immunomodulatory treatments in the 30 days before starting study drug.
  • Clinically significant impaired renal function as defined by a creatinine clearance <30 ml/min, calculated using the Cockcroft-Gault formula.
  • Clinically significant impaired hepatic function defined as an ALT (alanine transaminase) level > 5 times the normal upper limit.
  • Subjects with active liver disease.
  • Known to be hypersensitive to acyclovir, famciclovir, ganciclovir or any component of valaciclovir formulations.
  • Known resistance to acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir or valganciclovir.
  • Subjects with malabsorption or vomiting syndrome or other gastrointestinal dysfunction that might impair drug pharmacokinetics.
  • Women contemplating pregnancy within the duration of the study drug dosing period.
  • Women who are pregnant and/or nursing mothers
  • Current history of alcohol or drug abuse.
  • Received suppressive (daily) therapy for genital herpes prior to enrollment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158860

  Show 70 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00158860     History of Changes
Other Study ID Numbers: HS2100275
Study First Received: September 8, 2005
Last Updated: May 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
valaciclovir
genital herpes
HSV-2
Valtrex
suppression

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

ClinicalTrials.gov processed this record on July 22, 2014