- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03073967
Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects (PRIOH-1)
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)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The trial comprises 5 Parts, Part A, B, C, D, E and F.
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:
- present with foscarnet-resistance/intolerance, or
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:
- present with iv foscarnet resistance/intolerance already at Screening for inclusion, or
- 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:
- present with iv foscarnet resistance/intolerance already at Screening for inclusion, or
- 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).
- 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.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Córdoba, Argentina, 5000
- Recruiting
- Hospital Rawson
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Contact:
- Viviana David
- Phone Number: +54 351 551 1771
- Email: cic.hospitalrawson@gmail.com
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Córdoba, Argentina, 5000
- Recruiting
- Sanatorio Mayo Privado S.A.
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Contact:
- Maximiliano Ambasch
- Phone Number: +54 9 351 805-8266
- Email: infectologia_sanroque@yahoo.com.ar
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La Plata, Argentina, CP 1900
- Recruiting
- Instituto FIDES
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Contact:
- Paula Contarelli
- Phone Number: +54 221 5602642
- Email: contarellimp@gmail.com
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Parkville, Australia, 3050
- Recruiting
- Melbourne Health - Royal Melbourne Hospital
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Contact:
- Joanne Patterson
- Phone Number: +61 3 9342 2181
- Email: joan.patterson@mh.org.au
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Westmead, Australia, 2145
- Recruiting
- Westmead Hospital, Centre for Infectious Disease and Microbiology
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Contact:
- Neela Joshi Rai
- Phone Number: +61 2 8890 6251
- Email: Neela.JoshiRai@health.nsw.gov.au
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Brussels, Belgium, B1000
- Recruiting
- Centre Hospitalier Universitaire Saint Pierre
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Contact:
- Coca Necsoi
- Phone Number: +32 2 535 4747
- Email: coca.necsoi@stpierre-bru.be
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Roeselare, Belgium, 8800
- Recruiting
- AZ Delta
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Contact:
- Lies Breyne
- Phone Number: +32 51 23 75 86
- Email: lies.breyne@azdelta.be
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
- Recruiting
- Alberta Health Services Cross Cancer Institute at the University of Alberta
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Contact:
- Kim Robertson
- Phone Number: 7804076945
- Email: kimberly.robertson2@albertahealthservices.ca
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Limoges, France, 87042
- Recruiting
- CHU Limoges - Centre national de reference des Herpes virus
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Contact:
- Françoise Garnier-Geffroy
- Phone Number: +33 5 55 05 55 55
- Email: Francoise.GARNIER-GEOFFROY@chu-limoges.fr
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Nantes, France, 44093
- Recruiting
- CHU de Nantes
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Contact:
- jeremie orain
- Phone Number: +33 2 5348 2425
- Email: jeremie.orain@chu-nantes.fr
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Paris, France, 75010
- Recruiting
- Hôpital Saint Louis - AP-HP
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Contact:
- miresta previlon
- Phone Number: +33 1 42 49 99 25
- Email: miresta.previlon@aphp.fr
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Paris, France, 75015
- Recruiting
- AP-HP Hopital Necker-Enfants Malades
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Contact:
- Solimda Sotou Bere
- Phone Number: +33 1 44 49 45 33
- Email: solimda.sotoubere@aphp.fr
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Paris, France, 75018
- Recruiting
- AP-HP Hopital Bichat - Claude Bernard
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Contact:
- Lynda Chalal
- Phone Number: + 33 1 40 25 73 11
- Email: lynda.chalal@aphp.fr
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Tbilisi, Georgia, 0159
- Recruiting
- LLC Diakor
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Contact:
- Liza Peikrishvili
- Phone Number: +995 595 30 34 44
- Email: liziko5f@yahoo.com
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Tbilisi, Georgia, 0168
- Recruiting
- JSC Curatio
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Contact:
- Nelly Bakuradze
- Phone Number: +995 599 90 23 54
- Email: nelly_bakuradze@yahoo.com
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Tbilisi, Georgia, 0186
- Recruiting
- Multiprofile Clinic Consilium Medulla LTD
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Contact:
- Sopio Ghonghadze
- Phone Number: +995 591 70 89 17
- Email: sghonghadze@smo-pharmina.net
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Köln, Germany, 50937
- Recruiting
- Universitätsklinikum Köln
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Contact:
- Yasmin Habibullah
- Phone Number: +4922147896287
- Email: yasmin.habibullah@uk-koeln.de
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Muenchen, Germany, 81737
- Recruiting
- Muenchen Klinik Neuperlach
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Contact:
- baerbel hoell-neugebauer
- Phone Number: +49 89 6794 2737
- Email: baerbel.hoell-neugebauer@muenchen-klinik.de
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Athens, Greece, 11527
- Recruiting
- General Hospital of Athens - Laiko
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Contact:
- Maria Gamaletsou
- Phone Number: +30 6974957338
- Email: magama@med.uoa.gr
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Heraklion, Greece, 71110
- Recruiting
- Regional University General Hospital of Heraklion
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Contact:
- Anna Mathioudaki
- Phone Number: +30 69 8360 3822
- Email: mailto:mathiouanna94@gmail.com
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Tel-Hashomer, Israel, 5265601
- Recruiting
- Chaim Sheba Medical Center
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Contact:
- Kira Lozinsky
- Phone Number: +972 3 5305795
- Email: Kira.Lozinsky@sheba.health.gov.il
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Calabria, Italy, 89133
- Recruiting
- Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"
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Contact:
- Gaetana Porto
- Phone Number: +39 0965393886
- Email: tania.porto25@hotmail.it
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Milano, Italy, 20122
- Recruiting
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
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Contact:
- Giuseppe Lamorte
- Phone Number: 4323 + 39 02 55034036
- Email: giuseppe.lamorte@policlinico.mi.it
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Pavia, Italy, 27100
- Recruiting
- Fondazione IRCCS Policlinico San Matteo
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Contact:
- Alessandra Ferrari
- Phone Number: +39 0382503689
- Email: alessandra.ferrari@smatteo.pv.it
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Distrito Federal, Mexico, 03720
- Recruiting
- Centro de Investigación Clínica Gramel S.C.
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Contact:
- Montserrat Saro
- Phone Number: +52 55 4427 4848
- Email: m.saro@gramel.com.mx
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Durango, Mexico, 34000
- Recruiting
- Instituto de Investigaciones Aplicadas A La Neurociencia A.C
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Contact:
- Berenice Gonzalez
- Phone Number: +526181963882
- Email: pichisnichis@gmail.com
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Guadalajara, Mexico, 44160
- Recruiting
- Centro de Investigacion Farmaceutica Especializado de Occidente S.C.
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Contact:
- Misael Torres
- Phone Number: +52 33 3609 6229
- Email: MisaelTorres447@gmail.com
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Monterrey, Mexico, 64718
- Recruiting
- Unidad de Investigacion CIMA SC
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Contact:
- Flor Gomez
- Phone Number: +52 614 1333520
- Email: mailto:florgomex789@gmail.com
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Veracruz, Mexico, 91910
- Recruiting
- Arke SMO S.A. de C.V.
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Contact:
- Reyna Rojas Maulion
- Phone Number: +52 229 931 4102
- Email: r.rojas@arke.com.mx
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Genève, Switzerland, 1205
- Recruiting
- Hôpitaux Universitaires de Genève
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Contact:
- Cristina Boehm-Bosmani
- Phone Number: +41 79 234 15 27
- Email: Cristina.Boehm-Bosmani@hcuge.ch
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Zuerich, Switzerland, 8091
- Recruiting
- UniversitaetsSpital Zuerich
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Contact:
- Rheliana Katzensteiner
- Phone Number: +41 442553730
- Email: Rheliana.Katzensteiner@usz.ch
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London, United Kingdom, WC1E 6BT
- Recruiting
- Research Department of Haematology, UCL Cancer Institute
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Contact:
- Dorothy Marino
- Phone Number: +44 7971775175
- Email: dorothy.marino@nhs.net
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Newcastle Upon Tyne, United Kingdom, NE7 7DN
- Recruiting
- Freeman Hospital
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Contact:
- Bijal Patel
- Phone Number: +44 01912825045
- Email: Bijal.Patel4@nhs.net
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Alabama
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Birmingham, Alabama, United States, 35205
- Recruiting
- University of Alabama at Birmingham
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Contact:
- Garner Melissa
- Phone Number: 205-597-6242
- Email: mdgarner@uabmc.edu
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Arizona
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Tucson, Arizona, United States, 85724
- Recruiting
- University Arizona - Department of Medicine Arizona Health Sciences Center
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Contact:
- Jose Elizondo
- Phone Number: 520-621-0316
- Email: joselizondo5@arizona.edu
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California
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Duarte, California, United States, 91010
- Recruiting
- City of Hope
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Contact:
- Lindsay Poehlmann
- Phone Number: 619-693-8026
- Email: Lpoehlman@coh.org
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Los Angeles, California, United States, 90048
- Recruiting
- Cedars-Sinai Medical Center
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Contact:
- Maurice Herring
- Phone Number: 310-248-7134
- Email: Maurice.Herring@cshs.org
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Contact:
- Allison Peterson
- Email: Allison.peterson@csmns.org
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Sacramento, California, United States, 95817
- Recruiting
- University of California, Division of Infectious Diseases
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Contact:
- Christine Wangeci Gichigi
- Phone Number: 916 734 6942
- Email: cwgichigi@ucdavis.edu
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Contact:
- Jaimie Kimberly Figueroa
- Phone Number: 916 734 6942
- Email: jkfigueroa@ucdavis.edu
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Connecticut
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New Haven, Connecticut, United States, 06510
- Recruiting
- Yale University School of Medicine - Infectious Diseases
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Contact:
- Rodolfo N. Molina, M.D.
- Phone Number: 203-785-7031
- Email: Rodolfo.molina@yale.edu
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Florida
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DeLand, Florida, United States, 32720
- Recruiting
- Midland Florida Clinical Research Center, LLC
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Contact:
- Svetlana Shiloh
- Phone Number: 386-279-6181
- Email: svetlana.mfcrc@gmail.com
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Fort Pierce, Florida, United States, 34982
- Recruiting
- Midway Immunology and Research Center (MIRC)
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Contact:
- Carly Sharp
- Phone Number: 772-595-9830
- Email: info@midwayresearch.com
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Gainesville, Florida, United States, 32610
- Recruiting
- University of Florida (UF) - Division of Infectious Disease
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Contact:
- Steven Fowler
- Phone Number: 352-294-5277
- Email: stevenfowler@ufl.edu
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Miami, Florida, United States, 33176
- Recruiting
- Links Clinical Trials
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Contact:
- Yelamis Cartaya
- Phone Number: 305-363-2767
- Email: ycartaya@lctrials.com
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Miami, Florida, United States, 33175
- Recruiting
- Palmetto Professional Research
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Contact:
- Yadira Alfonso
- Phone Number: 208-346-8900
- Email: yalfonso@palmettoproresearch.com
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Georgia
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Atlanta, Georgia, United States, 30308
- Recruiting
- Emory Hospital Midtown Infectious Disease Clinic
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Contact:
- Joan Lopez
- Phone Number: 404-686-5198
- Email: jllopez@emory.edu
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Illinois
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Chicago, Illinois, United States, 60612
- Recruiting
- Department of Medicine J. H. Stroger Hospital of Cook County
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Contact:
- Mieoak Bahk
- Phone Number: 312-572-4543
- Email: mbahk@cookcountyhhs.org
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Louisiana
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Baton Rouge, Louisiana, United States, 70809
- Recruiting
- LSU Health Baton Rouge Pulmonary Clinic
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Contact:
- Jennifer Daigle
- Phone Number: 225-757-4150
- Email: jdai11@lsuhsc.edu
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New Orleans, Louisiana, United States, 70112
- Recruiting
- Tulane University - School of Medicine
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Contact:
- James Eden
- Phone Number: 504-988-9803
- Email: ejames7@tulane.edu
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Maryland
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Baltimore, Maryland, United States, 21205
- Recruiting
- Johns Hopkins University School of Medicine
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Contact:
- Obi Ezennia
- Phone Number: 410-614-6702
- Email: oezenni1@jhmi.edu
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Recruiting
- Brigham and Women's Hospital
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Contact:
- Natalie Izaguirre
- Phone Number: 617-525-9339
- Email: NatalieE_Izaguirre@dfci.harvard.edu
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Nebraska
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Omaha, Nebraska, United States, 68198
- Recruiting
- University of Nebraska Medical Center
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Contact:
- M. Grace Rodriguez
- Phone Number: 402-559-6244
- Email: mrodrigu@unmc.edu
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New York
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New York, New York, United States, 10021
- Recruiting
- David H. Koch Center at Memorial Sloan Kettering Cancer Center
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Contact:
- Gyuri Han
- Phone Number: 646-608-2776
- Email: HanG1@mskcc.org
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Recruiting
- Atrium Health Wake Forest Baptist
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Contact:
- Rica Abbott
- Phone Number: 336-713-1395
- Email: rabbott@wakehealth.edu
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Ohio
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Cincinnati, Ohio, United States, 45229
- Recruiting
- Cincinnati Children's Hospital Medical Center
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Contact:
- Kerrigan Perkins
- Phone Number: 513-636-1882
- Email: kerrigan.perkins@cchmc.org
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
- Recruiting
- University of Pittsburgh Medical Center
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Contact:
- Ellen Morell
- Phone Number: 412-648-6553
- Email: morelle@upmc.edu
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Texas
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Houston, Texas, United States, 77030-4009
- Recruiting
- MD Anderson Cancer Center
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Contact:
- Gloria Araujo
- Phone Number: 713-745-6110
- Email: gbaraujo@mdanderson.org
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Washington
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Seattle, Washington, United States, 98109
- Recruiting
- Fred Hutchinson Cancer Research Center
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Contact:
- Rachel Blazevic
- Phone Number: 206-667-6624
- Email: rblazevi@fredhutch.org
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Part C inclusion criteria
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).
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
- 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.
Part D (complete) exclusion criteria
All exclusion criteria as for Part C, except criterion 12, which is replaced by:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
100 mg oral tablets
|
Experimental: 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
|
100 mg oral tablets
|
Experimental: 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
|
100 mg oral tablets
|
Experimental: 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
|
100 mg oral tablets
|
Active Comparator: 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. |
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy measured by cure rate
Time Frame: Up to a maximum of 28 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy measured by cure rate
Time Frame: Up to a maximum of 42 days
|
Number of subjects cured (all lesions healed as assessed by the Investigator) during the treatment period of up to 42 days relative to the total number of subjects treated with trial medication in the respective treatment group.
|
Up to a maximum of 42 days
|
Efficacy measured by time to lesion healing
Time Frame: Up to a maximum of 42 days
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Time to lesion healing, defined as complete epithelization of the mucocutaneous HSV lesion(s) within the treatment period and no appearance of new lesions, as assessed by the Investigator.
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Up to a maximum of 42 days
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Efficacy measured by recurrence rate
Time Frame: At 2 months following post treatment visit, from randomization up to a maximum of 108 days
|
Recurrence rate at 2 months following PoTV assessed by telephone, defined as number of subjects with a recurrence as assessed by the Investigator following 2/3 months after PoTV relative to the total number of subjects assessed for recurrence at the respective telephone call per treatment.
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At 2 months following post treatment visit, from randomization up to a maximum of 108 days
|
Efficacy measured by recurrence rate
Time Frame: At 3 months following post treatment visit, from randomization up to a maximum of 139 days
|
Recurrence rate at 3 months following PoTV assessed by telephone, defined as number of subjects with a recurrence as assessed by the Investigator following 2/3 months after PoTV relative to the total number of subjects assessed for recurrence at the respective telephone call per treatment.
|
At 3 months following post treatment visit, from randomization up to a maximum of 139 days
|
Efficacy measured by pain rate
Time Frame: Up to a maximum of 42 days
|
Number of days with pain at lesion site relative to the total number of days with analyzable pain data through daily subject self-reporting
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Up to a maximum of 42 days
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Efficacy measured by time to pain cessation at site of lesion
Time Frame: Up to a maximum of 42 days
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Starting at first dose of trial medication until pain is no longer reported by the subject (date and time)
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Up to a maximum of 42 days
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Efficacy measured by average pain score
Time Frame: Up to a maximum of 42 days
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Using a single-dimensional scale assessing pain intensity through daily subject self-reporting
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Up to a maximum of 42 days
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Efficacy measured by clinical shedding rate
Time Frame: From date of randomization until the date of first documented healing, assessed up to a maximum of 42 days
|
Number of HSV positive swabs per subject relative to the total number of swabs collected per subject from lesion swabs taken from HSV lesion(s)
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From date of randomization until the date of first documented healing, assessed up to a maximum of 42 days
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Efficacy measured by time to cessation of shedding
Time Frame: Up to a maximum of 42 days
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Number of days until swabs taken are negative
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Up to a maximum of 42 days
|
Efficacy measured by mean log number of HSV DNA copies
Time Frame: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
|
Mean log number of HSV DNA copies on HSV DNA positive swabs from lesion(s) as detected by quantitative real-time PCR (polymerase chain reaction).
|
From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
|
Efficacy measured by resistance to trial medication
Time Frame: From date of randomization until the date of post treatment visit, assessed up to a maximum of 73 days
|
Resistance to trial medication for lesions not healed within the treatment period or newly appeared lesions under treatment before or at the PoTV.
|
From date of randomization until the date of post treatment visit, assessed up to a maximum of 73 days
|
Safety measured by number of subjects developing chronic kidney disease
Time Frame: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
|
Chronic kidney disease
|
From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
|
Safety measured by percentage of subjects developing chronic kidney disease
Time Frame: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
|
Chronic kidney disease
|
From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
|
Safety measured by percentage of subjects developing renal impairment
Time Frame: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
|
Renal impairment
|
From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
|
Safety measured by adverse events
Time Frame: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
|
Incidence of Adverse Events
|
From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
|
Safety measured by haematology
Time Frame: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
|
Incidence of abnormal hematologic laboratory test results
|
From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
|
Safety measured by lymphadenopathy
Time Frame: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
|
Incidence of lymphadenopathy measured by physical examination
|
From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
|
Safety measured by CRP (C reactive protein )
Time Frame: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
|
Incidence of CRP increase
|
From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
|
Safety measured by cutaneous adverse events
Time Frame: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
|
Incidence of cutaneous adverse events by physical examination
|
From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
|
Safety measured by (a)PTT (partial thromboplastin time)
Time Frame: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
|
Incidence of (a)PTT increase
|
From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
|
Safety measured by percentage of subjects developing acute Kidney Injury
Time Frame: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
|
Acute Kidney Injury (AKI) stage >1 of KDIGO (Kidney Disease: Improving Global Outcome) criteria (increase in serum creatinine by 2.0 to 2.9 times compared to baseline or urine output <0.5 mL/kg/h for >12 hours)
|
From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
|
Safety measured by percentage of subjects developing electrolyte abnormality
Time Frame: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
|
All abnormal values
|
From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
|
Safety measured by percentage of subjects developing seizures
Time Frame: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
|
All seizures
|
From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
|
Safety measured by percentage of subjects developing anemia
Time Frame: From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
|
Haemoglobin measurement
|
From date of randomization until the date of safety follow-up visit, assessed up to a maximum of 73 days
|
Safety measured by discontinuation rate
Time Frame: Up to a maximum of 42 days
|
Number of subjects discontinuing pritelivir or 'Inverstigator's Choice' due to AE(s) or intolerance relative to the total number of subjects treated with pritelivir or foscarnet, respectively
|
Up to a maximum of 42 days
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Skin Diseases
- Virus Diseases
- Disease Attributes
- DNA Virus Infections
- Skin Diseases, Infectious
- Skin Diseases, Viral
- Herpesviridae Infections
- Infections
- Communicable Diseases
- Herpes Simplex
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Interferon Inducers
- Imiquimod
- Cidofovir
- Foscarnet
- Pritelivir
Other Study ID Numbers
- AIC316-03-II-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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