VALTREX Once Daily For Viral Shedding In Herpes Simplex Virus 2 (HSV-2) Seropositive Subjects

Condition(s) targeted: Genital Herpes

Intervention: Valaciclovir (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trial, MD, Study Director, 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 between treatment periods.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Two-Way Crossover Study to Investigate the Effect of VALTREX 1g Once Daily for 60 Days on Viral Shedding in HSV-2 Seropositive Subjects With No Previous History of Symptomatic Genital Herpes Infection.

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

Primary outcome: To determine the effect of valaciclovir 1g once daily for 60 days on HSV-2 viral shedding.

Secondary outcome: To determine the safety of valaciclovir 1g once daily for 60 days in healthy subjects with no previous history of symptomatic genital herpes infection.

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

Criteria:

Inclusion Criteria:

- In overall general good health.

- HSV-2 (Herpes Simplex Virus-2) seropositive at screening.

Exclusion criteria:

- have active lesions consistent with genital herpes.

- previous history of symptomatic genital herpes.

- history of recurrent, undiagnosed symptoms consistent with genital herpes.

GSK Clinical Trials Call Center, Birmingham, Alabama 35294-3293, United States

GSK Clinical Trials Call Center, Davis, California 95616, United States

GSK Clinical Trials Call Center, San Diego, California 92182-4701, United States

GSK Clinical Trials Call Center, Riverside, California 92506, United States

GSK Clinical Trials Call Center, Sacramento, California 95825, United States

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

GSK Clinical Trials Call Center, Ft. Lauderdale, Florida 33328, United States

GSK Clinical Trials Call Center, Atlanta, Georgia 30322, United States

GSK Clinical Trials Call Center, Oak Brook, Illinois 60523-1818, 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, Boston, Massachusetts 02115-2683, United States

GSK Clinical Trials Call Center, Boston, Massachusetts 02118-2393, United States

GSK Clinical Trials Call Center, Bronx, New York 10461, United States

GSK Clinical Trials Call Center, Stony Brook, New York 11794-8091, United States

GSK Clinical Trials Call Center, New York, New York 10011, United States

GSK Clinical Trials Call Center, New York, New York 10029-6501, 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, Houston, Texas 77058, United States

GSK Clinical Trials Call Center, Salt Lake City, Utah 84132-2405, United States

GSK Clinical Trials Call Center, Seattle, Washington 98122, United States

Starting date: March 2005
Last updated: June 12, 2007