A Study Comparing Daily Treatment With Valaciclovir To Placebo For Suppression Of Herpes Simplex Virus HSV-2 Genital Herpes In Newly Diagnosed Patients
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
- To determine the efficacy of administering valaciclovir 1 gram once daily for 6 months
- vs. placebo for genital herpes suppressive therapy in immunocompetent newly diagnosed
- subjects, the primary endpoint is time to first genital herpes recurrence
- Secondary measures include: adverse events, serious adverse events, etc.
- Number of genital herpes recurrences within the study period
- Time to first oral HSV outbreak
- Collection of HSV-2 culture isolates to assess for resistance to acyclovir.
|Study Start Date:||June 2004|
|Study Completion Date:||July 2006|
|Primary Completion Date:||July 2006 (Final data collection date for primary outcome measure)|
Drug: valaciclovir (Valtrex)
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|Study Director:||GSK Clinical Trials, MD||GlaxoSmithKline|