valtrex(valacyclovir) once daily for viral shedding in subjects newly diagnosed with hsv-2

Conditions: Herpes Labialis

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.

Keywords: recurrent genital herpes