* PRIOH-1
Research type
Research Study
Full title
A randomized, open-label, multi-center, comparative trial, to assess the efficacy and safety of pritelivir versus foscarnet for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised subjects (PRIOH-1)
IRAS ID
295684
Contact name
Minal Kara
Contact email
Sponsor organisation
AiCuris Anti-infective Cures GmbH
Eudract number
2020-004940-27
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Lesions of the mucous membranes (in the mouth) and lesions on the skin, called mucocutaneous lesions, are the most evident sign of herpes simplex virus (HSV) disease. In patients with an intact immune system, the ulcers are usually small in size, with mild pain and self-limiting. In patients with an impaired immune system, the ulcers are usually extensive, deep and associated with severe pain.
Standard treatment with acyclovir, valacyclovir and foscarnet is no longer working, due to resistance and as such patients experience more frequent episodes of reactivation, prolonged duration of symptoms and shedding of virus, increased severity of infection, and extensive lesions.
There are 3 parts to the study. In each part pritelivir will be given orally (by mouth) at a dose of 100mg per day for a maximum of 42 days.
The purpose of Part C is to look at the safety and effectiveness of pritelivir compared to the standard treatment, foscarnet, which has to be applied in a vein, in patients with an impaired immune system who have lesions caused by the form of HSV that does not react to acyclovir.
The purpose of Part D is to look at the safety and effectiveness of pritelivir in patients with an impaired immune system who have lesions caused by the form of HSV that does not respond to treatment with acyclovir and foscarnet or in whom foscarnet cannot be given due to intolerance.
The purpose of Part E is to look at the safety and effectiveness of pritelivir in patients with an impaired immune system who have recurrent lesions caused by the form of HSV that does respond to treatment with acyclovir.
AiCuris Anti-infective Cures AG., is sponsoring this multicentre study being conducted worldwide.REC name
London - Brent Research Ethics Committee
REC reference
21/FT/0081
Date of REC Opinion
5 Aug 2021
REC opinion
Further Information Favourable Opinion