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New hope for Drug-Resistant herpes in vulnerable patients

NCT ID NCT03073967

Disease control Sponsor: AiCuris Anti-infective Cures AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new oral drug called pritelivir against standard treatments (foscarnet, cidofovir, or imiquimod) for herpes infections that no longer respond to acyclovir. It involved 158 immunocompromised participants, such as those with HIV or organ transplants. The goal was to see if pritelivir could heal lesions faster and more safely.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pritelivir (oral tablet)
What this could lead to
If it works, this could provide a new treatment option for people with weakened immune systems who have herpes infections that don't respond to standard acyclovir therapy.
What could go wrong
This is a completed Phase 3 trial, but results are not yet widely available. The drug may not prove superior to existing treatments like foscarnet or cidofovir, which have their own side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

158 people

The number who actually took part.

Started

May 2017

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Part C inclusion criteria 1. Immunocompromised men and women of any ethnic group aged ≥16 years. In Canada, Germany, Belgium: Immunocompromised (due to conditions including but not limited to HIV infection, hematopoietic cell or solid organ transplantation, and chronic use of immunosuppressive treatment) men and women of any ethnic group aged \>18 years. 2. ACV-R mucocutaneous HSV infection based on clinical failure or positive genotypic/phenotypic ACV resistance testing for current lesion. Clinical failure is defined as no improvement after oral or iv doses for at least 7 days at doses equivalent to or greater than the local agency approved high oral doses of acyclovir, valacyclovir or famciclovir. 3. Lesions accessible for visual inspection to allow assessment of lesion healing including visualization by endoscopy. 4. Willingness to use highly effective birth control. 5. Subject, and/or their legally authorized representative, (proxy consent is not permitted in Germany), must be willing and able to understand the Informed Consent Form. 6. Negative serum β-HCG (beta-human chorionic gonadotropin) test for women of child-bearing potential at Screening and a negative urine pregnancy test at Day 1. 7. Written informed consent. For subjects, who are unable to provide informed consent for whatever reason, written consent must be obtained from the legal representative, (proxy consent is not permitted in Germany). Part D and F inclusion criteria All inclusion criteria as for Part C, except for inclusion criterion 2, which is replaced by: 2\. ACV-R and foscarnet-R mucocutaneous HSV infection based on clinical failure or positive genotypic/phenotypic resistance testing for current lesion or documented intolerance to iv foscarnet requiring cessation of foscarnet treatment or precluding foscarnet treatment. Subjects will be able to enter Part F only after closure of enrollment in Part D. Part E inclusion (Part E is not being conducted in Germany) All inclusion criteria as for Part C, except for inclusion criterion 2, which is replaced by: 2\. Recurrent mucocutaneous HSV infection considered ACV-S. Part C exclusion criteria 1. Known resistance/intolerance to pritelivir or any of the excipients. 2. Previous treatment in PRIOH-1. 3. Baseline safety laboratory abnormalities. 4. History or current evidence of gastrointestinal malabsorption which, in the opinion of the Investigator, may affect the extent of absorption of pritelivir. 5. Hemodialysis for any indication and ESRD (eGFR \<15 mL/min; stage 5 CKD) 6. History or current evidence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric, or other relevant diseases. 7. Abnormalities in hematological, clinical chemical or any other laboratory variables. 8. Not able to communicate meaningfully with the Investigator and site staff. 9. Any other condition which in the opinion of the Investigator would interfere with successful completion of this clinical trial. 10. Any other important local condition. 11. Pregnant and/or breastfeeding women. 12. Having received an investigational drug in an investigational drug trial unter certain conditions. Part D (complete) exclusion criteria All exclusion criteria as for Part C, except criterion 12, which is replaced by: 13. Having received an investigational drug in an investigational trial within 7 half-lives after the last administration of this drug before initiating trial medication, except for subjects entering Part D, who have previously received foscarnet treatment in Part C of this trial. Participation in a clinical trial without receiving other investigational drugs (eg, follow-up phase of a trial, observational study) is permitted. Part E exclusion criteria (Part E is not being conducted in Germany) All exclusion criteria in Part E are identical to those in Part C with the addition of: 13\. Having used acyclovir, valacyclovir, or famciclovir within 3 days prior to starting pritelivir. Part F exclusion criteria All exclusion criteria for Part D plus 13. Part D open for enrollment

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Conditions

The condition(s) this trial relates to.

herpes simplex infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HSV infection

Contacts and locations

Locations

  • AP-HP Hopital Bichat - Claude Bernard

    Paris, 75018, France

  • AP-HP Hopital Necker-Enfants Malades

    Paris, 75015, France

  • ARENSIA Exploratory Medicine LLC

    Kyiv, 01135, Ukraine

  • AZ Delta

    Roeselare, 8800, Belgium

  • AZ Sint-Jan Brugge

    Bruges, 8000, Belgium

  • Alberta Health Services Cross Cancer Institute at the University of Alberta

    Edmonton, Alberta, T6G 1Z2, Canada

  • Arke SMO S.A. de C.V.

    Veracruz, 91910, Mexico

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina, 27157, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • CHU Limoges - Centre national de reference des Herpes virus

    Limoges, 87042, France

  • CHU de Nantes

    Nantes, 44093, France

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Centre Hospitalier Universitaire Saint Pierre

    Brussels, B1000, Belgium

  • Centro de Investigacion Clinica GRAMEL S.C.

    Distrito Federal, 03720, Mexico

  • Centro de Investigacion Farmaceutica Especializado de Occidente S.C.

    Guadalajara, 44160, Mexico

  • Chaim Sheba Medical Center

    Tel Litwinsky, 5265601, Israel

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • City of Hope

    Duarte, California, 91010, United States

  • David H. Koch Center at Memorial Sloan Kettering Cancer Center

    New York, New York, 10021, United States

  • Department of Medicine J. H. Stroger Hospital of Cook County

    Chicago, Illinois, 60612, United States

  • Duke University Medical Center - Division of Infectious Diseases

    Durham, North Carolina, 27710, United States

  • Emory Hospital Midtown Infectious Disease Clinic

    Atlanta, Georgia, 30308, United States

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

    Milan, 20122, Italy

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100, Italy

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109, United States

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • General Hospital of Athens - Laiko

    Athens, 11527, Greece

  • Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"

    Calabria, 89133, Italy

  • Hopitaux universitaires de Geneve

    Geneva, 1205, Switzerland

  • Hospital Rawson

    Córdoba, 5000, Argentina

  • Hôpital Saint Louis - AP-HP

    Paris, 75010, France

  • Instituto FIDES

    La Plata, CP 1900, Argentina

  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C

    Durango, 34000, Mexico

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21205, United States

  • Kings Country Hospital Center

    Brooklyn, New York, 11203, United States

  • LLC Diakor

    Tbilisi, 0159, Georgia

  • LSU Health Baton Rouge Pulmonary Clinic

    Baton Rouge, Louisiana, 70809, United States

  • Lee's Summit MO United States 64086

    Lee's Summit, Missouri, 64086, United States

  • Links Clinical Trials

    Miami, Florida, 33176, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030-4009, United States

  • Melbourne Health - Royal Melbourne Hospital

    Parkville, 3050, Australia

  • Metro Infectious Disease Consultants - Atlanta

    Decatur, Georgia, 30033, United States

  • Metro Infectious Disease Consultants, LLC

    Burr Ridge, Illinois, 60527, United States

  • Metro Infectious Disease Consultants, LLC - Huntsville

    Huntsville, Alabama, 35801, United States

  • Midland Florida Clinical Research Center, LLC

    DeLand, Florida, 32720, United States

  • Midway Immunology and Research Center (MIRC)

    Ft. Pierce, Florida, 34982, United States

  • Multiprofile Clinic Consilium Medulla LTD

    Tbilisi, 0186, Georgia

  • Nhs Lothian

    Edinburgh, EH4 2XU, United Kingdom

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Regional University General Hospital of Heraklion

    Heraklion, 71110, Greece

  • Research Department of Haematology, UCL Cancer Institute

    London, WC1E 6BT, United Kingdom

  • Rutgers Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901, United States

  • Sanatorio Mayo Privado S.A.

    Córdoba, 5000, Argentina

  • Tulane University - School of Medicine

    New Orleans, Louisiana, 70112, United States

  • Unidad de Investigacion CIMA SC

    Chihuahua City, 64718, Mexico

  • Universitaetsspital Basel

    Basel, 4031, Switzerland

  • Universitaetsspital Zuerich

    Zurich, 8091, Switzerland

  • University Arizona - Department of Medicine Arizona Health Sciences Center

    Tucson, Arizona, 85724, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35205, United States

  • University of California, Division of Infectious Diseases

    Sacramento, California, 95817, United States

  • University of Florida (UF) - Division of Infectious Disease

    Gainesville, Florida, 32610, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University of South Alabama

    Mobile, Alabama, 36604, United States

  • University of South Florida

    Tampa, Florida, 33606, United States

  • Universitätsklinikum Essen

    Essen, 45147, Germany

  • Universitätsklinikum Köln

    Cologne, 50937, Germany

  • Universitätsklinikum Würzburg

    Würzburg, 97080, Germany

  • Westmead Hospital, Centre for Infectious Disease and Microbiology

    Westmead, 2145, Australia