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

NCT03073967 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: AIC316-03-II-01
• Study Type: interventional
• Target: 158
• Locations: 15 countries
• Sites: 70

Brief 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).

Conditions

HSV Infection

Outcome Measures

Primary Outcomes (1)

• Efficacy measured by cure rate

  Number of subjects cured (all lesions healed as assessed by the Investigator) during the treatment period of up to 28 days relative to the total number of subjects treated with trial medication in the respective treatment group.

  Up to a maximum of 28 days

Secondary Outcomes (25)

• Efficacy measured by cure rate

  Up to a maximum of 42 days

• Efficacy measured by time to lesion healing

  Up to a maximum of 42 days

• Efficacy measured by recurrence rate

  At 2 months following post treatment visit, from randomization up to a maximum of 108 days

• Efficacy measured by recurrence rate

  At 3 months following post treatment visit, from randomization up to a maximum of 139 days

• Efficacy measured by pain rate

  Up to a maximum of 42 days

Study Arms (5)

Part C, Pritelivir

EXPERIMENTAL

Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days

Drug: Pritelivir

Part C,

ACTIVE COMPARATOR

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.

Drug: Investigator's choice

Part D, Pritelivir

EXPERIMENTAL

Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days

Drug: Pritelivir

Part E, Pritelivir

EXPERIMENTAL

Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days

Drug: Pritelivir

Part F, Pritelivir

EXPERIMENTAL

Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days

Drug: Pritelivir

Interventions

Pritelivir DRUG

100 mg oral tablets

Part C, Pritelivir; Part D, Pritelivir; Part E, Pritelivir; Part F, Pritelivir

Investigator's choice DRUG

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

Also known as: Foscarnet or Cidofovir or Imiquimod

Part C,

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Lesions accessible for visual inspection to allow assessment of lesion healing including visualization by endoscopy.
• Willingness to use highly effective birth control.
• 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.
• 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.
• 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).
• \. 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.
• \. Recurrent mucocutaneous HSV infection considered ACV-S.

You may not qualify if:

• Known resistance/intolerance to pritelivir or any of the excipients.
• Previous treatment in PRIOH-1.
• Baseline safety laboratory abnormalities.
• History or current evidence of gastrointestinal malabsorption which, in the opinion of the Investigator, may affect the extent of absorption of pritelivir.
• Hemodialysis for any indication and ESRD (eGFR \<15 mL/min; stage 5 CKD)
• History or current evidence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric, or other relevant diseases.
• Abnormalities in hematological, clinical chemical or any other laboratory variables.
• Not able to communicate meaningfully with the Investigator and site staff.
• Any other condition which in the opinion of the Investigator would interfere with successful completion of this clinical trial.
• Any other important local condition.
• Pregnant and/or breastfeeding women.
• Having received an investigational drug in an investigational drug trial unter certain conditions.
• 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.
• \. Having used acyclovir, valacyclovir, or famciclovir within 3 days prior to starting pritelivir.

Sponsors & Collaborators

• AiCuris Anti-infective Cures AG: lead
• Medpace, Inc.: collaborator

Study Sites (70)

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

Location

Metro Infectious Disease Consultants, LLC - Huntsville

Hunstville, Alabama, 35801, United States

Location

University of South Alabama

Mobile, Alabama, 36604, United States

Location

University Arizona - Department of Medicine Arizona Health Sciences Center

Tuscon, Arizona, 85724, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California, Division of Infectious Diseases

Sacramento, California, 95817, United States

Location

Midland Florida Clinical Research Center, LLC

DeLand, Florida, 32720, United States

Location

Midway Immunology and Research Center (MIRC)

Ft. Pierce, Florida, 34982, United States

Location

University of Florida (UF) - Division of Infectious Disease

Gainesville, Florida, 32610, United States

Location

Links Clinical Trials

Miami, Florida, 33176, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Emory Hospital Midtown Infectious Disease Clinic

Atlanta, Georgia, 30308, United States

Location

Metro Infectious Disease Consultants - Atlanta

Decatur, Georgia, 30033, United States

Location

Metro Infectious Disease Consultants, LLC

Burr Ridge, Illinois, 60527, United States

Location

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

Chicago, Illinois, 60612, United States

Location

LSU Health Baton Rouge Pulmonary Clinic

Baton Rouge, Louisiana, 70809, United States

Location

Tulane University - School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Lee's Summit MO United States 64086

Lee's Summit, Missouri, 64086, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

Kings Country Hospital Center

Brooklyn, New York, 11203, United States

Location

David H. Koch Center at Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Duke University Medical Center - Division of Infectious Diseases

Durham, North Carolina, 27710, United States

Location

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Hospital Rawson

Córdoba, 5000, Argentina

Location

Sanatorio Mayo Privado S.A.

Córdoba, 5000, Argentina

Location

Instituto FIDES

La Plata, CP 1900, Argentina

Location

Melbourne Health - Royal Melbourne Hospital

Parkville, 3050, Australia

Location

Westmead Hospital, Centre for Infectious Disease and Microbiology

Westmead, 2145, Australia

Location

AZ Sint-Jan Brugge

Bruges, 8000, Belgium

Location

Centre Hospitalier Universitaire Saint Pierre

Brussels, B1000, Belgium

Location

AZ Delta

Roeselare, 8800, Belgium

Location

Alberta Health Services Cross Cancer Institute at the University of Alberta

Edmonton, Alberta, T6G 1Z2, Canada

Location

CHU Limoges - Centre national de reference des Herpes virus

Limoges, 87042, France

Location

CHU de Nantes

Nantes, 44093, France

Location

Hôpital Saint Louis - AP-HP

Paris, 75010, France

Location

AP-HP Hopital Necker-Enfants Malades

Paris, 75015, France

Location

AP-HP Hopital Bichat - Claude Bernard

Paris, 75018, France

Location

LLC Diakor

Tbilisi, 0159, Georgia

Location

Multiprofile Clinic Consilium Medulla LTD

Tbilisi, 0186, Georgia

Location

Universitätsklinikum Köln

Cologne, 50937, Germany

Location

Universitätsklinikum Essen

Essen, 45147, Germany

Location

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

General Hospital of Athens - Laiko

Athens, 11527, Greece

Location

Regional University General Hospital of Heraklion

Heraklion, 71110, Greece

Location

Chaim Sheba Medical Center

Tel Litwinsky, 5265601, Israel

Location

Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"

Calabria, 89133, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

Milan, 20122, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Unidad de Investigacion CIMA SC

Chihuahua City, 64718, Mexico

Location

Centro de Investigacion Clinica GRAMEL S.C.

Distrito Federal, 03720, Mexico

Location

Instituto de Investigaciones Aplicadas a la Neurociencia A.C

Durango, 34000, Mexico

Location

Centro de Investigacion Farmaceutica Especializado de Occidente S.C.

Guadalajara, 44160, Mexico

Location

Arke SMO S.A. de C.V.

Veracruz, 91910, Mexico

Location

Universitaetsspital Basel

Basel, 4031, Switzerland

Location

Hopitaux universitaires de Geneve

Geneva, 1205, Switzerland

Location

Universitaetsspital Zuerich

Zurich, 8091, Switzerland

Location

ARENSIA Exploratory Medicine LLC

Kyiv, 01135, Ukraine

Location

Nhs Lothian

Edinburgh, EH4 2XU, United Kingdom

Location

Research Department of Haematology, UCL Cancer Institute

London, WC1E 6BT, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

MeSH Terms

Conditions

Herpes Simplex

Interventions

pritelivir; Foscarnet; Cidofovir; Imiquimod

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphonoacetic Acid; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Organophosphonates; Organophosphorus Compounds; Cytosine; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 8, 2017
• Study Start: May 8, 2017
• Primary Completion: August 15, 2025
• Study Completion: November 11, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (33); AU (2); IL (1); FR (5); ME (5); GB (3); BE (3); AR (3); GE (2); CH (3); GR (2); CA (1); UA (1); DE (3); IT (3)