Expanded Access Intermediate Size Treatment Protocol: Pritelivir for Immunocompromised Subjects with Treatment Resistant Herpes Simplex Virus Type 1 or 2
Plain-language 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.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Immunocompromised (due to conditions including but not limited to HIV infection, hematopoietic-cell or solid organ transplantation, and chronic use of immunosupressive treatment) men and women of any ethnic group aged ≥16 years.
. ACV-resistant and foscarnet-resistant/intolerant mucocutaneous HSV infection based on clinical failure (no improvement after oral or iv doses for at least 7 days at doses equivalent to or greater than the local agency approved high doses of valacyclovir or famciclovir and/or foscarnet iv therapy or intolerance to foscarnet requiring cessation of foscarnet treatment) or result from genotypic/phenotypic testing or ACV-resistant and previously treated in PRIOH-1 Part C.
. The current lesion(s) should be confirmed to be positive for HSV before the start of treatment. If not tested beforehand, a lesion swab should be taken for PCR or cell culture before starting treatment, but treatment may be started before obtaining results.
. Visual confirmation of lesion at start of treatment (including by endoscopy).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Willing to remain abstinent or use highly effective method of contraception.
. Negative pregnancy test for females of childbearing potential at Day 1 and every 4 weeks thereafter.
. Patient must be willing and able (in the opinion of the physician) to understand the informed consent form.
. Patient must give written informed consent.
Exclusion criteria
. Eligibility and feasibility for a patient to participate in a currently ongoing clinical trial with pritelivir.
. Known intolerance to pritelivir or any of the excipients (microcrystalline cellulose, croscarmellose sodium, mannitol, colloidal anhydrous silica, magnesium stearate, hydroxy propyl methyl cellulose, polyethylene glycol, calcium diphosphate).
. Need to use the following medications at any dose: esomeprazole, rabeprazole. Need to use the medications with the following daily dose levels: omeprazole \> 20 mg/d, lansoprazole \> 20 mg/d or pantoprazole \> 80 mg/d.