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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00158860 |
Genital herpes (GH) is a commonly occurring sexually transmitted disease caused by herpes simplex virus (HSV). There are two types of HSV, type 1 (HSV-1) and type 2 (HSV-2); both can cause GH, although the latter is much more likely to produce frequent recurrences of GH lesions. Evidence suggests that there are advantages to using suppressive vs. episodic treatment, which include increased intervals between the pain and discomfort of genital herpes recurrences. Therefore, this study will collect safety and efficacy data on suppressive therapy with valaciclovir in subjects newly diagnosed with HSV-2 genital herpes.
Condition | Intervention | Phase |
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Genital Herpes |
Drug: valaciclovir (Valtrex) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An International, Randomized, Double-Blind, Placebo-Controlled, Multicenter, 6- Month Study of the Efficacy and Safety of Valaciclovir 1g Once Daily vs. Placebo for the Suppression of HSV-2 Genital Herpes in Newly Diagnosed Immunocompetent Subjects |
Estimated Enrollment: | 315 |
Study Start Date: | June 2004 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | HS2100275 |
Study First Received: | September 8, 2005 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00158860 |
Health Authority: | United States: Food and Drug Administration |
genital herpes HSV-2 valaciclovir Valtrex suppression |
Valacyclovir Genital Diseases, Female Virus Diseases Herpes Simplex Sexually Transmitted Diseases, Viral Acyclovir |
Herpes Genitalis Sexually Transmitted Diseases DNA Virus Infections Genital Diseases, Male Herpesviridae Infections |
Anti-Infective Agents Therapeutic Uses Antiviral Agents Pharmacologic Actions |