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Antiviral
Pritelivir vs Foscarnet for Resistant Herpes (PRIOH-1 Trial)
Phase 3
Recruiting
Research Sponsored by AiCuris Anti-infective Cures GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Immunocompromised men and women of any ethnic group aged ≥16 years.
Immunocompromised (due to conditions including HIV infection, hematopoietic cell or solid organ transplantation, and chronic glucocorticoid use) men and women of any ethnic group aged >18 years.
Timeline
Screening 1 days
Treatment Varies
Follow Up 4 days
Awards & highlights
PRIOH-1 Trial Summary
This trial is testing two different drugs to see which is more effective and has fewer side effects in people with HSV infections that are resistant or susceptible to acyclovir.
Who is the study for?
This trial is for immunocompromised adults over 18 years old with mucocutaneous HSV infections resistant to acyclovir. Participants must be willing to use effective birth control and have lesions that can be visually inspected. Pregnant women, individuals unable to consent, or those not following specific treatment protocols are excluded.Check my eligibility
What is being tested?
The study compares the effectiveness of Pritelivir tablets (with an initial high dose) against Foscarnet injections in treating herpes infections in people with weakened immune systems. It's a randomized and open-label trial, meaning both researchers and participants know which treatment is given.See study design
What are the potential side effects?
Potential side effects may include nausea, headache, fatigue, kidney issues from Foscarnet; while Pritelivir might cause gastrointestinal symptoms or changes in blood tests monitoring liver function.
PRIOH-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 16 or older and have a weakened immune system.
Select...
I am over 18 and have a weakened immune system due to certain conditions.
Select...
My HSV infection didn't improve after 7 days of standard treatment, requiring a switch to foscarnet.
Select...
My lesions can be seen and checked by doctors using special tools.
Select...
You must agree to use very effective birth control methods.
PRIOH-1 Trial Timeline
Screening ~ 1 days1 visit
Treatment ~ Varies
Follow Up ~ 4 days2 visits
Screening ~ 1 days
Treatment ~ Varies
Follow Up ~4 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Efficacy measured by average pain score
Efficacy measured by clinical shedding rate
Efficacy measured by cure rate
+22 moreSide effects data
From 2020 Phase 1 trial • 16 Patients • NCT055136256%
Skin abrasion
6%
Ankle fracture
6%
Tooth impacted
100%
80%
60%
40%
20%
0%
Study treatment Arm
100 mg Pritelivir
40 mg qd ESO and 100 mg Pritelivir
PRIOH-1 Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Part F, PritelivirExperimental Treatment1 Intervention
Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days
Group II: Part E, PritelivirExperimental Treatment1 Intervention
Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days
Group III: Part D, PritelivirExperimental Treatment1 Intervention
Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days
Group IV: Part C, PritelivirExperimental Treatment1 Intervention
Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days
Group V: Part C, FoscarnetActive Control1 Intervention
iv solution, 40 mg/kg tid or 60mg/kg bid for up to 28 days and potential prolongation for up to additional 14 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pritelivir
2020
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
AiCuris Anti-infective Cures GmbHLead Sponsor
4 Previous Clinical Trials
742 Total Patients Enrolled
AiCuris Anti-infective Cures AGLead Sponsor
8 Previous Clinical Trials
1,850 Total Patients Enrolled
Medpace, Inc.Industry Sponsor
94 Previous Clinical Trials
29,462 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must be able to understand the information provided in the Informed Consent Form, and agree to participate in the study.I am 16 or older and have a weakened immune system.I have given or my legal representative has given written consent for me to participate.You must agree to use very effective birth control methods.My HSV infection didn't improve after 7 days of standard treatment, requiring a switch to foscarnet.You are currently receiving medical care at MD Anderson.Women who could be pregnant must have a negative pregnancy test before starting the study.This criterion is incomplete and needs further information to provide a summary. Please provide additional details.I am over 18 and have a weakened immune system due to certain conditions.My lesions can be seen and checked by doctors using special tools.I agree not to apply lotions or creams to my HSV lesions, but I can use saline dressings.
Research Study Groups:
This trial has the following groups:- Group 1: Part C, Pritelivir
- Group 2: Part C, Foscarnet
- Group 3: Part D, Pritelivir
- Group 4: Part E, Pritelivir
- Group 5: Part F, Pritelivir
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 1 Days to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 28 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 4 Months after you stop receiving the treatment.
Herpes Patient Testimony for trial: Trial Name: NCT03073967 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does Pritelivir carry any significant health risks?
"Pritelivir has received a safety score of 3. This is based on the fact that it is a Phase 3 trial, meaning there is both evidence of efficacy and multiple rounds worth of data to support its safety."
Answered by AI
Are there numerous locations where this experiment is taking place?
"This trial is currently underway at 25 sites, for example Cincinnati Children's Hospital Medical Center in Cincinnati, John Hopkins University School of Medicine in Baltimore, and the University of Nebraska Medical Center in Omaha."
Answered by AI
Is this a groundbreaking clinical trial?
"Pritelivir has been under investigation since 2017 by AiCuris Anti-infective Cures GmbH. The first study, which took place in 153 participants, led to Pritelivir's Phase 3 approval. Currently, there is only one active trial for this medication."
Answered by AI
What other scientific literature is there on Pritelivir?
"Pritelivir is being studied in 1 ongoing Phase 3 trial, with a total of 56 clinical sites across the world."
Answered by AI
Which viral infections does Pritelivir typically treat?
"Pritelivir is an effective course of treatment for immunocompromised patients, those with communicable diseases, and those taking acyclovir."
Answered by AI
What is the total number of individuals enrolled in this research project?
"153 patients that meet the required standards will take part in this clinical trial. The sponsor, AiCuris Anti-infective Cures GmbH, will administer the study from different locations; for example, Cincinnati Children's Hospital Medical Center situated in Cincinnati, Ohio and John Hopkins University School of Medicine based in Baltimore, Maryland."
Answered by AI
Are people still able to join this clinical trial?
"That is correct. The trial, which was first posted on May 8th 2017 and last updated November 10th 2020, is seeking 153 individuals from 25 different sites to participate."
Answered by AI
Who else is applying?
What state do they live in?
New York
California
Texas
Other
How old are they?
< 18
65+
18 - 65
What site did they apply to?
David H. Koch Center at Memorial Sloan Kettering Cancer Center
Cedars-Sinai Medical Center
University of California, Division of Infectious Diseases
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
1
3+
0
What questions have other patients asked about this trial?
Is this a paid trial? How long do screening visits take? How often will I need to check in and drive to Louisiana?
PatientReceived 1 prior treatment
Yes is this a cure or is this something to supress the outbreaks? Can this trail potentially help my cure and rid myself from HSV-1?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
Just wanna get rid of this virus. I’ve tried valetex it works at tji. Having genital herpes for a long time.
PatientReceived 1 prior treatment
Hoping to improve treatments for hepes. Other drugs don't always work prophylactically.
PatientReceived 1 prior treatment
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Phone Call
Email
Most responsive sites:
- MD Anderson Cancer Center: < 24 hours
- Yale University School of Medicine - Infectious Diseases: < 24 hours
- Emory Hospital Midtown Infectious Disease Clinic: < 24 hours
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