NCT05844436

Expanded Access Intermediate Size Treatment Protocol: Pritelivir for Immunocompromised Subjects with Treatment Resistant Herpes Simplex Virus Type 1 or 2

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: AiCuris Anti-infective Cures AG · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: —

Summary

AiCuris Anti-infective Cures AG (AiCuris) is developing pritelivir for the oral treatment of acyclovir-resistant (ACV-R) mucocutaneous herpes simplex virus (HSV) infections in immunocompromised subjects. The purpose of the expanded access program (EAP) is to provide pritelivir to immunocompromised subjects with treatment resistant HSV type 1 or 2 who cannot participate in a clinical trial and for whom no approved treatment option is available. In view of the available pre-clinical and clinical data for pritelivir in immunocompromised subjects with treatment resistant HSV, the lack of treatment options, and the demand for compassionate use of pritelivir, AiCuris aims to provide access to pritelivir via this expanded access program (intermediate size treatment protocol) in the USA. The patient population is focused on those immunocompromised subjects that are not responding to the available FDA-approved antiviral options or cannot use these because of an underlying medical condition. This EAP enables pritelivir to be available as a treatment option for immunocompromised subjects with treatment-resistant HSV type 1 or 2, who do not have access to clinical trial options.

Detailed description

This is a multicenter EAP (via intermediate size treatment protocol) designed to provide access to pritelivir for eligible immunocompromised subjects that are not responding to the available FDA-approved antiviral options or cannot use these because of an underlying medical condition, and who cannot enter a clinical trial. The program will continue until pritelivir becomes available through other mechanisms, or until Sponsor chooses to discontinue the program. Each subject considered for the EAP will undergo minimal assessment at baseline for lesion assessment and safety (laboratory tests and general physical evaluation). After eligibility check and starting the treatment, the subjects will be monitored on a weekly basis.

Conditions

• HSV

Interventions

Type	Name	Description
DRUG	Pritelivir	Participants receive a loading dose of 400 mg (4 x 100 mg tablet) pritelivir on first day followed by continuous dose of 100 mg per day.

Timeline

• First posted: 2023-05-06
• Last updated: 2025-02-10