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

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.

Timeline

Start

2012-10

Primary completion

2013-05

Completion

2013-07

Outcome

Met primary endpoint

registry analysis (superiority test); AIC316 vs Valacyclovir; p <0.0001; Risk Ratio (RR) 0.43 (95% CI 0.30 to 0.63) NCT01658826 ↗

Publications

• Wald A, Timmler B, Magaret A, Warren T, Tyring S, Johnston C, Fife K, Selke S, Huang ML, Stobernack HP, Zimmermann H, Corey L, Birkmann A, Ruebsamen-Schaeff H. Effect of Pritelivir Compared With Valacyclovir on Genital HSV-2 Shedding in Patients With Frequent Recurrences: A Randomized Clinical Trial. JAMA. 2016 Dec 20;316(23):2495-2503. doi: 10.1001/jama.2016.18189.

Drugs

Indications