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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00158860 |
Purpose
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 |
|---|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations
Show 70 Study Locations| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | HS2100275 |
| Study First Received: | September 8, 2005 |
| Last Updated: | June 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00158860 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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genital herpes HSV-2 valaciclovir Valtrex suppression |
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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 Acyclovir Therapeutic Uses Sexually Transmitted Diseases DNA Virus Infections |