Clinical Trial: Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: 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 Genit
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 Summary:
Sponsor: AiCuris Anti-infective Cures GmbH
Current Primary Outcome: Within-subject genital HSV mucocutaneous shedding rate: number of HSV positive swabs per subject relative to the total number of swabs collected per subject. [ Time Frame: 28 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: AiCuris Anti-infective Cures GmbH
Dates:
Date Received: August 3, 2012
Date Started: October 2012
Date Completion:
Last Updated: September 21, 2016
Last Verified: September 2016