Your session is about to expire
← Back to Search
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 day
Treatment Varies
Follow Up 4 days
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial compares two treatments for herpes infections in patients with weakened immune systems who do not respond to standard treatment. One treatment is a pill called pritelivir, and the other is a drug called foscarnet. Both aim to stop the virus from replicating and help heal sores. Foscarnet has been used to treat herpes viruses, including drug-resistant cytomegalovirus (CMV) and herpes simplex viruses types 1 and 2 (HSV-1 and HSV-2).
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.
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.
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.
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.
Timeline
Screening ~ 1 day1 visit
Treatment ~ Varies
Follow Up ~ 4 days2 visits
Screening ~ 1 day
Treatment ~ Varies
Follow Up ~4 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Efficacy measured by average pain score
Efficacy measured by clinical shedding rate
Efficacy measured by cure rate
+21 moreSide effects data
From 2020 Phase 1 trial • 16 Patients • NCT055136256%
Ankle fracture
6%
Skin abrasion
6%
Tooth impacted
100%
80%
60%
40%
20%
0%
Study treatment Arm
100 mg Pritelivir
40 mg qd ESO and 100 mg Pritelivir
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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,Active Control1 Intervention
Investigator's Choice:
Foscarnet iv, 40 mg/kg tid or 60mg/kg bid or Cidofovir iv, 5 mg/kg body weight given once weekly or Cidofovir 1% or 3%, topically applied 2 to 4 times daily or Imiquimod 5%, topically applied 3 times per week, 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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Pritelivir, a helicase-primase inhibitor, blocks the enzyme complex necessary for viral DNA replication, preventing the herpes virus from spreading. Foscarnet, a pyrophosphate analog, inhibits viral DNA polymerase by binding to its pyrophosphate binding site, stopping DNA chain elongation and viral replication.
These mechanisms are vital for herpes patients, especially those with drug-resistant infections, as they offer alternative treatment options that target the virus at a molecular level.
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
96 Previous Clinical Trials
29,724 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,
- Group 2: Part C, Pritelivir
- Group 3: Part D, Pritelivir
- Group 4: Part E, Pritelivir
- Group 5: Part F, Pritelivir
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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