Pritelivir is an innovative, therapeutic candidate inhibiting HSV replication and is in a pivotal phase 3 trial for the treatment of acyclovir-resistant HSV infections in immunocompromised patients. Derived from a novel chemical class (thiazolylamides), pritelivir is active against both types of herpes simplex virus (HSV-1 and HSV-2).
Besides causing highly recurrent labial and genital herpes infections in immune competent individuals, HSV symptoms in immunocompromised patients are often more severe including disseminated disease, meningitis and encephalitis and resistances to marketed drugs are often described.
Based on previous trials in which pritelivir showed promising efficacy with retained activity against viruses resistant to marketed drugs, favorable tolerability, and pharmacologic properties, pritelivir was granted Breakthrough Therapy Designation by the US FDA for the treatment of mucocutaneous HSV infections in immunocompromised patients.
(Source: AiCuris Anti-infective Cures AG - Pipeline)
Study participants will receive either pritelivir (oral) or one of the treatment regimens selected by your physician (foscarnet (iv), cidofovir (iv or topical) or imiquimod (topical)). You will be randomly assigned to one of the two treatment groups. The objective of this research study is to look at the safety and effectiveness of pritelivir compared to the available treatments (foscarnet, cidofovir, imiquimod).
There are potential risks and benefits in any clinical research study. Patients should only enroll in the PRIOH-1 study after careful discussion with a study doctor.
Potential benefits of participating in the PRIOH-1 study include:
Investigational means the study medication is not approved by regulatory authorities like the US Food and Drug Administration (FDA), and it can only be used in clinical research studies like PRIOH-1.