Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes

A Double-blind, Double Dummy, Randomized Crossover Trial to Compare the Effect of "AIC316 (Pritelivir)" 100 mg Once Daily Versus Valacyclovir 500 mg Once Daily on Genital HSV Shedding in HSV-2 Seropositive Adults.

The aim of the study is to evaluate the safety and efficacy of "AIC316 (pritelivir)" 100 mg once daily compared to valacyclovir 500 mg once daily for the prevention of HSV-2 genital shedding.

Enrolled patients with Mucocutaneous genital HSV, will be randomized to receive either AIC326 or Valacyclovir first and then will be crossed over to receive the opposite Intervention. The study will consist of two treatment periods of 28 days separated by a washout period of 28 days.

Inclusion Criteria:

• Adult, immunocompetent men and women in good health of any ethnic group
• Seropositive for Herpes Simplex Virus Type 2 (HSV-2)
• History of recurrent episodes (>=4 to <=9) of genital herpes for at least 12 months and willingness to obtain 4 swabs per day.

Exclusion Criteria:

• Present episode of genital herpes at time of randomization
• Clinically relevant acute or chronic infections (excluding HSV-2)
• Known intolerance to valacyclovir, acyclovir, or any component of the formulation
• Documented HSV resistance to acyclovir, valacyclovir, famciclovir or penciclovir