VALTREX(Valacyclovir) Once Daily for Viral Shedding In Subjects Newly Diagnosed With HSV-2
Condition: Herpes Labialis
MeSH terms: Herpes Simplex; Herpes Labialis
Intervention: valacyclovir
Intervention description: valacyclovir
Intervention MeSH terms: Valacyclovir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Recurrent Genital Herpes

Summary:

      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.
    

Eligibility 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.