Conditions: Genital Herpes
Keywords: AIC316 Viral shedding
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 91
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Participants first received AIC316 100 mg once daily for 28 days. After a washout period of 28 days, they then received Valacyclovir 500 mg once daily for 28 days. arm 2: Participants first received Valacyclovir 500 mg once daily for 28 days. After a washout period of 28 days, they then received AIC316 100 mg once daily for 28 days.

Interventions: intervention 1: AIC316 intervention 2: Valacyclovir
Intervention descriptions: intervention 1: 100 mg oral administration intervention 2: 500 mg oral administration

Protocol document: