Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects
NCT ID: NCT03073967
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
158 participants
INTERVENTIONAL
2017-05-08
2025-11-11
Brief Summary
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Detailed Description
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Part A and Part B (Phase 2) have been finalised.
* Part A is a randomized, open-label, multi-center, comparative design to assess the efficacy and safety in subjects with ACV-resistant mucocutaneous HSV infection, treated with oral pritelivir or intravenous foscarnet.
* Part B is an open-label, multi-center design to assess the efficacy and safety of pritelivir in subjects with ACV-resistant-mucocutaneous HSV and who either:
1. present with foscarnet-resistance/intolerance, or
2. developed foscarnet resistance/intolerance during treatment in Part A (no improvement after at least 5 days of foscarnet therapy or intolerance to foscarnet requiring cessation of foscarnet treatment).
Parts C, D, E and F (Phase 3).
* Part C is a randomized, open-label, multi-center, comparative design to assess the efficacy and safety of oral pritelivir in subjects with acyclovir resistent (ACV-R) mucocutaneous HSV episodes. Subjects with ACV-R mucocutaneous HSV infection will be randomized 1:1 to receive either oral pritelivir or Investigator's Choice.
This trial part is designed to show superiority of pritelivir against Investigator's Choice in obtaining clinical cure, ie, number of subjects with all lesions healed within 28 days.
* Part D is an open-label, multi-center design to assess the efficacy and safety of pritelivir in subjects with ACV-R mucocutaneous HSV episodes and who in addition either:
1. present with iv foscarnet resistance/intolerance already at Screening for inclusion, or
2. developed foscarnet resistance/intolerance during treatment in Part C (no improvement after at least 7 days of foscarnet treatment or intolerance to foscarnet requiring cessation of foscarnet treatment). Part D has been closed in June 2022.
* Part E is an open-label, multi-center design to assess the safety and efficacy of pritelivir in subjects with acyclovir susceptible (ACV-S) mucocutaneous HSV episodes, (Part E is not being conducted in Germany).
* Part F is an open-label, multi-center design to assess the efficacy and safety of pritelivir in subjects with ACV-R mucocutaneous HSV episodes and who in addition either:
1. present with iv foscarnet resistance/intolerance already at Screening for inclusion, or
2. developed foscarnet resistance/intolerance during treatment in Part C (no improvement after at least 7 days of foscarnet treatment or intolerance to foscarnet requiring cessation of foscarnet treatment).
3. cannot be enrolled into Part D anymore because enrollment into Part D has been completed.
Dosing of trial medication:
Pritelivir oral tablet as single daily doses of 100 mg (following a loading dose of 400 mg as first dose)
Comparator per investigator's choice (provided the drug listed below is nationally approved):
Foscarnet intermittent infusions of 40 mg/kg every 8 hours or 60 mg/kg every 12 hours (to be adjusted in case of renal impairment) for a minimum of 1 hour duration, or Cidofovir iv infusion of 5 mg/kg body weight given once weekly, or Cidofovir 1% or 3% topical treatment, applied 2 to 4 times daily, or Imiquimod 5% topical treatment, 3 times per week.
Duration of treatment:
Until all mucocutaneous HSV lesions are healed or up to 28 days, whichever is earlier.
A prolongation up to a maximum of 42 days may be possible depending on the clinical progress.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part C, Pritelivir
Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days
Pritelivir
100 mg oral tablets
Part C,
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.
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 D, Pritelivir
Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days
Pritelivir
100 mg oral tablets
Part E, Pritelivir
Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days
Pritelivir
100 mg oral tablets
Part F, Pritelivir
Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days
Pritelivir
100 mg oral tablets
Interventions
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Pritelivir
100 mg oral tablets
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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).
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)
2\. Recurrent mucocutaneous HSV infection considered ACV-S.
Exclusion Criteria
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.
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.
13\. Having used acyclovir, valacyclovir, or famciclovir within 3 days prior to starting pritelivir.
16 Years
ALL
No
Sponsors
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Medpace, Inc.
INDUSTRY
AiCuris Anti-infective Cures AG
INDUSTRY
Responsible Party
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Locations
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General Hospital of Athens - Laiko
Athens, , Greece
University of Alabama at Birmingham
Birmingham, Alabama, United States
Metro Infectious Disease Consultants, LLC - Huntsville
Hunstville, Alabama, United States
University of South Alabama
Mobile, Alabama, United States
University Arizona - Department of Medicine Arizona Health Sciences Center
Tuscon, 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
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
Countries
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Other Identifiers
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AIC316-03-II-01
Identifier Type: -
Identifier Source: org_study_id
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