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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00116844 |
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.
Condition | Intervention | Phase |
---|---|---|
Genital Herpes |
Drug: Valaciclovir |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Crossover Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 65 |
Study Start Date: | March 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
United States, California | |
GSK Investigational Site | |
Riverside, California, United States, 92506 | |
GSK Investigational Site | |
Sacramento, California, United States, 92585 | |
GSK Investigational Site | |
Carmichael, California, United States, 95608 | |
GSK Investigational Site | |
Davis, California, United States, 95616 | |
United States, Indiana | |
GSK Investigational Site | |
Fort Wayne, Indiana, United States, 46804 | |
GSK Investigational Site | |
Indianapolis, Indiana, United States, 46202 | |
United States, Massachusetts | |
GSK Investigational Site | |
Boston, Massachusetts, United States, 02115 | |
United States, New York | |
GSK Investigational Site | |
New York, New York, United States, 10029 | |
GSK Investigational Site | |
New York, New York, United States, 10011 | |
United States, North Carolina | |
GSK Investigational Site | |
Chapel Hill, North Carolina, United States, 27599 | |
United States, Oklahoma | |
GSK Investigational Site | |
Tulsa, Oklahoma, United States, 74104 | |
United States, Oregon | |
GSK Investigational Site | |
Portland, Oregon, United States, 97210 | |
United States, Texas | |
GSK Investigational Site | |
Houston, Texas, United States, 77030 | |
United States, Utah | |
GSK Investigational Site | |
Salt Lake City, Utah, United States, 84132 | |
United States, Washington | |
GSK Investigational Site | |
Seattle, Washington, United States, 98104 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | VLX103596 |
Study First Received: | June 30, 2005 |
Last Updated: | October 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00116844 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Recurrent |
Valacyclovir Genital Diseases, Female Virus Diseases Herpes Simplex Sexually Transmitted Diseases, Viral Herpes Genitalis |
Sexually Transmitted Diseases DNA Virus Infections Genital Diseases, Male Antiviral Agents Recurrence Herpesviridae Infections |
Herpes Simplex Anti-Infective Agents Sexually Transmitted Diseases, Viral Herpes Genitalis Genital Diseases, Male Antiviral Agents Pharmacologic Actions |
Herpesviridae Infections Virus Diseases Genital Diseases, Female Valacyclovir Therapeutic Uses Sexually Transmitted Diseases DNA Virus Infections |