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.

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.