NCT01658826

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.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: AiCuris Anti-infective Cures AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Genital Herpes

Interventions

Type	Name	Description
DRUG	AIC316	100 mg oral administration
DRUG	Valacyclovir	500 mg oral administration

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-05-01
• Completion: 2013-07-01
• First posted: 2012-08-07
• Last updated: 2023-04-21
• Results posted: 2023-04-21

Locations

4 sites across 1 country: United States