A Study Comparing Daily Treatment With Valaciclovir To Placebo For Suppression Of Herpes Simplex Virus HSV-2 Genital Herpes In Newly Diagnosed Patients. VALTREX® Tablet is a Trademark of the GlaxoSmithKline Group of Companies.
Condition: Herpes Genitalis
MeSH terms: Herpes Simplex; Herpes Genitalis
Intervention: Valaciclovir; Placebo
Intervention description: 1g once daily; placebo
Intervention MeSH terms: Valacyclovir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 384.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: VALTREX®; valaciclovir; genital herpes; HSV-2; suppression

Summary:

      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.
    

Eligibility 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.