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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Genital Herpes; Infections, Herpesviridae

Intervention: Valaciclovir (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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 between treatment periods.

Clinical Details

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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.

Eligibility

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.

Locations and Contacts

GSK Investigational Site, Carmichael, California 95608, United States

GSK Investigational Site, Davis, California 95616, United States

GSK Investigational Site, Riverside, California 92506, United States

GSK Investigational Site, Sacramento, California 92585, United States

GSK Investigational Site, Fort Wayne, Indiana 46804, United States

GSK Investigational Site, Indianapolis, Indiana 46202, United States

GSK Investigational Site, Boston, Massachusetts 02115, United States

GSK Investigational Site, New York, New York 10011, United States

GSK Investigational Site, New York, New York 10029, United States

GSK Investigational Site, Chapel Hill, North Carolina 27599, United States

GSK Investigational Site, Tulsa, Oklahoma 74104, United States

GSK Investigational Site, Portland, Oregon 97210, United States

GSK Investigational Site, Houston, Texas 77030, United States

GSK Investigational Site, Salt Lake City, Utah 84132, United States

GSK Investigational Site, Seattle, Washington 98104, United States

Additional Information

Starting date: March 2005
Last updated: March 17, 2011

Page last updated: August 23, 2015

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