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NCT03073967

PHASE3

Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects

Sponsor: AiCuris Anti-infective Cures AG

View on ClinicalTrials.gov

Summary

Randomized, open-label, multi-center, comparative trial to assess the efficacy and safety in immunocompromised subjects with acyclovir resistant or acyclovir susceptible mucocutaneous HSV infection, treated with pritelivir 100 mg once daily (following a loading dose of 400 mg as first dose to rapidly reach steady-state plasma concentration) or investigators choice, which can be either foscarnet 40 mg/kg every 8 hours or 60 mg/kg every 12 hours, or Cidofovir iv 5 mg/kg body weight given once weekly, or Cidofovir 1% or 3% topical applied 2 to 4 times daily, or Imiquimod 5% topical 3 times per week) (provided the drug is nationally approved).

Official title: A Randomized, Open Label, Multi-center, Comparative Trial, to Assess the Efficacy and Safety of Pritelivir for the Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects (PRIOH-1)

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

INTERVENTIONAL

Enrollment

158

Start Date

2017-05-08

Completion Date

2025-11-11

Last Updated

2026-06-12

Healthy Volunteers

Conditions

HSV Infection

Interventions

DRUG

Pritelivir

100 mg oral tablets

DRUG

Investigator's choice

Foscarnet iv, 40 mg/kg BW tid or 60mg/kg bid or Cidofovir iv, 5 mg/kg BW given once weekly or Cidofovir 1% or 3%, topically applied 2 to 4 times daily or Imiquimod 5%, Solution for iv infusion or topical application

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

Locations (70)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Metro Infectious Disease Consultants, LLC - Huntsville

Huntsville, Alabama, United States

University of South Alabama

Mobile, Alabama, United States

University Arizona - Department of Medicine Arizona Health Sciences Center

Tucson, Arizona, United States

City of Hope

Duarte, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of California, Division of Infectious Diseases

Sacramento, California, United States

Midland Florida Clinical Research Center, LLC

DeLand, Florida, United States

Midway Immunology and Research Center (MIRC)

Ft. Pierce, Florida, United States

University of Florida (UF) - Division of Infectious Disease

Gainesville, Florida, United States

Links Clinical Trials

Miami, Florida, United States

University of South Florida

Tampa, Florida, United States

Emory Hospital Midtown Infectious Disease Clinic

Atlanta, Georgia, United States

Metro Infectious Disease Consultants - Atlanta

Decatur, Georgia, United States

Metro Infectious Disease Consultants, LLC

Burr Ridge, Illinois, United States

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

Chicago, Illinois, United States

LSU Health Baton Rouge Pulmonary Clinic

Baton Rouge, Louisiana, United States

Tulane University - School of Medicine

New Orleans, Louisiana, United States

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

University of Minnesota

Minneapolis, Minnesota, United States

Lee's Summit MO United States 64086

Lee's Summit, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Kings Country Hospital Center

Brooklyn, New York, United States

David H. Koch Center at Memorial Sloan Kettering Cancer Center

New York, New York, United States

Duke University Medical Center - Division of Infectious Diseases

Durham, North Carolina, United States

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

MD Anderson Cancer Center

Houston, Texas, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Hospital Rawson

Córdoba, Argentina

Sanatorio Mayo Privado S.A.

Córdoba, Argentina

Instituto FIDES

La Plata, Argentina

Melbourne Health - Royal Melbourne Hospital

Parkville, Australia

Westmead Hospital, Centre for Infectious Disease and Microbiology

Westmead, Australia

AZ Sint-Jan Brugge

Bruges, Belgium

Centre Hospitalier Universitaire Saint Pierre

Brussels, Belgium

AZ Delta

Roeselare, Belgium

Alberta Health Services Cross Cancer Institute at the University of Alberta

Edmonton, Alberta, Canada

CHU Limoges - Centre national de reference des Herpes virus

Limoges, France

CHU de Nantes

Nantes, France

Hôpital Saint Louis - AP-HP

Paris, France

AP-HP Hopital Necker-Enfants Malades

Paris, France

AP-HP Hopital Bichat - Claude Bernard

Paris, France

LLC Diakor

Tbilisi, Georgia

Multiprofile Clinic Consilium Medulla LTD

Tbilisi, Georgia

Universitätsklinikum Köln

Cologne, Germany

Universitätsklinikum Essen

Essen, Germany

Universitätsklinikum Würzburg

Würzburg, Germany

General Hospital of Athens - Laiko

Athens, Greece

Regional University General Hospital of Heraklion

Heraklion, Greece

Chaim Sheba Medical Center

Tel Litwinsky, Israel

Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"

Calabria, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

Milan, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Unidad de Investigacion CIMA SC

Chihuahua City, Mexico

Centro de Investigacion Clinica GRAMEL S.C.

Distrito Federal, Mexico

Instituto de Investigaciones Aplicadas a la Neurociencia A.C

Durango, Mexico

Centro de Investigacion Farmaceutica Especializado de Occidente S.C.

Guadalajara, Mexico

Arke SMO S.A. de C.V.

Veracruz, Mexico

Universitaetsspital Basel

Basel, Switzerland

Hopitaux universitaires de Geneve

Geneva, Switzerland

Universitaetsspital Zuerich

Zurich, Switzerland

ARENSIA Exploratory Medicine LLC

Kyiv, Ukraine

Nhs Lothian

Edinburgh, United Kingdom

Research Department of Haematology, UCL Cancer Institute

London, United Kingdom

Freeman Hospital

Newcastle upon Tyne, United Kingdom

Clinical Research Directory

Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (70)