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

Condition(s) targeted: Genital Herpes

Intervention: valacyclovir (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trial, MD, Study Chair, Affiliation: GlaxoSmithKline

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.

Official title: The Effect of Valacyclovir 1g Once Daily on HSV-2 Viral Shedding in Subjects Newly Diagnosed With Genital Herpes Infection

Study design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study

Primary outcome: Effect of VALTREX administered once daily for 60 days versus placebo on total HSV-2 shedding in immunocompetent subjects newly diagnosed with HSV-2 infection.

Secondary outcome: Safety of VALTREX 1g administered once daily for 60 days in immunocompetent HSV-2 seropositive subjects newly diagnosed with HSV-2 infection.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

GSK Clinical Trials Call Center, Carmichael, California 95608, United States

GSK Clinical Trials Call Center, Sacramento, California 95816, United States

GSK Clinical Trials Call Center, San Diego, California 92123, United States

GSK Clinical Trials Call Center, Anaheim, California 92805, United States

GSK Clinical Trials Call Center, Carmichael, California 95608, United States

GSK Clinical Trials Call Center, Huntington Park, California 90255, United States

GSK Clinical Trials Call Center, St. Petersburg, Florida 33710, United States

GSK Clinical Trials Call Center, Boynton Beach, Florida 33437, United States

GSK Clinical Trials Call Center, South Bend, Indiana 46601, United States

GSK Clinical Trials Call Center, Indianapolis, Indiana 46202, United States

GSK Clinical Trials Call Center, Portage, Michigan 49024, United States

GSK Clinical Trials Call Center, New York, New York 10029, United States

GSK Clinical Trials Call Center, Winston-Salem, North Carolina 27103, United States

GSK Clinical Trials Call Center, Raleigh, North Carolina 27607, United States

GSK Clinical Trials Call Center, Tulsa, Oklahoma 74104, United States

GSK Clinical Trials Call Center, Portland, Oregon 97210, United States

GSK Clinical Trials Call Center, Philadelphia, Pennsylvania 19140, United States

GSK Clinical Trials Call Center, Memphis, Tennessee 38104, United States

GSK Clinical Trials Call Center, Memphis, Tennessee 38120, United States

Starting date: February 2006
Last updated: June 12, 2007