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


Active: Yes
Cancer Type: NCT ID: NCT05844436
Trial Phases: Protocol IDs: AIC316-03-E-01 (primary)
Eligibility: 16 Years and older (Child, Adult, Older Adult ), Male and Female Study Type:
Study Sponsor: AiCuris Anti-infective Cures AG
NCI Full Details:

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.

Treatment Sites in Georgia

Northside Hospital Cancer Institute - Bone Marrow Transplant (BMT)
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-851-8523


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