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

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.