What is the PRIOH-1 study?

The PRIOH-1 study is for people who are immunocompromised (because of conditions such as HIV infection, solid organ transplantation, certain cancers, or long-term steroid use), who also have herpes simplex virus (HSV-1 and HSV-2) skin lesions.

The purpose of this study is to compare the efficacy and safety of the study drug, pritelivir, to the investigator’s choice of either foscarnet IV, cidofovir IV, or topical imiquimod against these acyclovir intolerant mucocutaneous (i.e. skin) HSV infections, which cannot be treated with acyclovir. Pritelivir will be taken by mouth as single daily doses until all mucocutaneous HSV lesions are healed or up to a maximum of 42 days, whichever is earlier.

Who can join the PRIOH-1 study?

Study participants may be able to join the study if they meet the following requirements:

-16 years of age or older

Are immunocompromised (because of conditions such as HIV infection, organ transplantation, or long-term steroid use)

-HSV infection that has not responded to acyclovir treatment
-Or foscarnet was discontinued because of resistance or intolerance

Other study requirements will apply

What will happen during the study?

Participation in the PRIOH-1 study lasts up to a maximum of 152 days following initial screening.

Study participants can expect the following:

Review & sign the Informed Consent Form:
You will need to read and sign the Informed Consent Form (ICF) before you receive any study assessments.

Confirm Study Requirements:‍
Receive study health assessments to confirm if you qualify for the study. This is called a screening. Screening health assessments will include a physical examination, an ECG (heart test), a urine pregnancy test, blood tests, and a visual check of your lesions.

Be assigned to a study group:
Depending on what treatments you have already tried; you will be assigned to one of several groups.

Take either treatment chosen by your physician (foscarnet iv, cidofovir iv, or imiquimod topical) or pritelivir:
‍Depending on your study group assignment, you will either receive IV infusions of foscarnet or cidofovir, or topical imiquimod, or take pritelivir tablets by mouth.

Visit the study site weekly:
‍‍You will visit the study site once a week for 4-5 weeks for study health assessments. 4 weeks after your last dose, you will return to the study site for final study health assessments.

Answer phone calls:
‍‍A member of the study staff will call you at 8 weeks (about 2 months) and 13 weeks (about 3 months) after your last study site visit to ask if your lesions have returned.

PRIOH-1 Study

What is the PRIOH-1 study?

Who can join the PRIOH-1 study?

What will happen during the study?