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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

153

Participants

Timeline

Start Date

May 8, 2017

Primary Completion Date

August 15, 2025

Study Completion Date

November 30, 2025

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

Trial Locations (70)

1205

Hopitaux universitaires de Geneve, Geneva

2145

Westmead Hospital, Centre for Infectious Disease and Microbiology, Westmead

3050

Melbourne Health - Royal Melbourne Hospital, Parkville

4031

Universitaetsspital Basel, Basel

5000

Hospital Rawson, Córdoba

Sanatorio Mayo Privado S.A., Córdoba

8000

AZ Sint-Jan Brugge, Bruges

8091

Universitaetsspital Zuerich, Zurich

8800

AZ Delta, Roeselare

10021

David H. Koch Center at Memorial Sloan Kettering Cancer Center, New York

11203

Kings Country Hospital Center, Brooklyn

11527

General Hospital of Athens - Laiko, Athens

15232

University of Pittsburgh Medical Center, Pittsburgh

17033

Penn State Health Milton S. Hershey Medical Center, Hershey

20122

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, Milan

21205

Johns Hopkins University School of Medicine, Baltimore

27100

Fondazione IRCCS Policlinico San Matteo, Pavia

27157

Atrium Health Wake Forest Baptist, Winston-Salem

27710

Duke University Medical Center - Division of Infectious Diseases, Durham

30033

Metro Infectious Disease Consultants - Atlanta, Decatur

30308

Emory Hospital Midtown Infectious Disease Clinic, Atlanta

32610

University of Florida (UF) - Division of Infectious Disease, Gainesville

32720

Midland Florida Clinical Research Center, LLC, DeLand

33176

Links Clinical Trials, Miami

33606

University of South Florida, Tampa

34000

Instituto de Investigaciones Aplicadas a la Neurociencia A.C, Durango

34982

Midway Immunology and Research Center (MIRC), Ft. Pierce

35205

University of Alabama at Birmingham, Birmingham

35801

Metro Infectious Disease Consultants, LLC - Huntsville, Hunstville

36604

University of South Alabama, Mobile

44093

CHU de Nantes, Nantes

44160

Centro de Investigacion Farmaceutica Especializado de Occidente S.C., Guadalajara

45147

Universitätsklinikum Essen, Essen

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

50937

Universitätsklinikum Köln, Cologne

55455

University of Minnesota, Minneapolis

60527

Metro Infectious Disease Consultants, LLC, Burr Ridge

60612

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

64086

Lee's Summit MO United States 64086, Lee's Summit

64718

Unidad de Investigacion CIMA SC, Chihuahua City

68198

University of Nebraska Medical Center, Omaha

70112

Tulane University - School of Medicine, New Orleans

70809

LSU Health Baton Rouge Pulmonary Clinic, Baton Rouge

71110

Regional University General Hospital of Heraklion, Heraklion

75010

Hôpital Saint Louis - AP-HP, Paris

75015

AP-HP Hopital Necker-Enfants Malades, Paris

75018

AP-HP Hopital Bichat - Claude Bernard, Paris

85724

University Arizona - Department of Medicine Arizona Health Sciences Center, Tuscon

87042

CHU Limoges - Centre national de reference des Herpes virus, Limoges

89133

"Grande Ospedale Metropolitano Bianchi Melacrino Morelli", Calabria

90048

Cedars-Sinai Medical Center, Los Angeles

91010

City of Hope, Duarte

91910

Arke SMO S.A. de C.V., Veracruz

95817

University of California, Division of Infectious Diseases, Sacramento

97080

Universitätsklinikum Würzburg, Würzburg

98109

Fred Hutchinson Cancer Research Center, Seattle

5265601

Chaim Sheba Medical Center, Tel Litwinsky

02115

Brigham and Women's Hospital, Boston

08901

Rutgers Robert Wood Johnson Medical School, New Brunswick

77030-4009

MD Anderson Cancer Center, Houston

CP 1900

Instituto FIDES, La Plata

B1000

Centre Hospitalier Universitaire Saint Pierre, Brussels

T6G 1Z2

Alberta Health Services Cross Cancer Institute at the University of Alberta, Edmonton

0159

LLC Diakor, Tbilisi

0186

Multiprofile Clinic Consilium Medulla LTD, Tbilisi

03720

Centro de Investigacion Clinica GRAMEL S.C., Distrito Federal

01135

ARENSIA Exploratory Medicine LLC, Kyiv

EH4 2XU

Nhs Lothian, Edinburgh

WC1E 6BT

Research Department of Haematology, UCL Cancer Institute, London

NE7 7DN

Freeman Hospital, Newcastle upon Tyne

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Medpace, Inc.

INDUSTRY

lead

AiCuris Anti-infective Cures AG

INDUSTRY