A Study Comparing Daily Treatment With Valaciclovir To Placebo For Suppression Of Herpes Simplex Virus HSV-2 Genital Herpes In Newly Diagnosed Patients. VALTREX® Tablet is a Trademark of the GlaxoSmithKline Group of Companies.

Summary

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.

Timeline

Start

2004-06-21

Primary completion

2006-07-26

Completion

2006-07-26

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Valaciclovir 1g QD; p <0.001; Hazard Ratio (HR) 0.401 (95% CI 0.282 to 0.570); Log Rank NCT00158860 ↗

Drugs

Indications