Conditions: Herpes Genitalis
Keywords: VALTREX® valaciclovir genital herpes HSV-2 suppression
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 384
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants received double blinded treatment of oral dose of Valacyclovir 1 g given as 2 x 500 mg caplets QD for 6 months (24 weeks). arm 2: Participants received double blinded treatment of oral dose of matching placebo to Valacyclovir 1 gram (g) given as 2 x 500 milligram (mg) caplets once daily (QD) for 6 months (24 weeks).

Interventions: intervention 1: Valaciclovir intervention 2: Placebo
Intervention descriptions: intervention 1: 1g once daily intervention 2: placebo

Protocol document: