COMPLETED

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2017-05-08
Study Completion:2025-11-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT03073967

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35205
United States
Metro Infectious Disease Consultants, LLC - Huntsville
Hunstville, Alabama, 35801
United States
University of South Alabama
Mobile, Alabama, 36604
United States
University Arizona - Department of Medicine Arizona Health Sciences Center
Tuscon, Arizona, 85724
United States
City of Hope
Duarte, California, 91010
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
University of California, Division of Infectious Diseases
Sacramento, California, 95817
United States
Midland Florida Clinical Research Center, LLC
DeLand, Florida, 32720
United States
Midway Immunology and Research Center (MIRC)
Ft. Pierce, Florida, 34982
United States
University of Florida (UF) - Division of Infectious Disease
Gainesville, Florida, 32610
United States
Links Clinical Trials
Miami, Florida, 33176
United States
University of South Florida
Tampa, Florida, 33606
United States
Emory Hospital Midtown Infectious Disease Clinic
Atlanta, Georgia, 30308
United States
Metro Infectious Disease Consultants - Atlanta
Decatur, Georgia, 30033
United States
Metro Infectious Disease Consultants, LLC
Burr Ridge, Illinois, 60527
United States
Department of Medicine J. H. Stroger Hospital of Cook County
Chicago, Illinois, 60612
United States
LSU Health Baton Rouge Pulmonary Clinic
Baton Rouge, Louisiana, 70809
United States
Tulane University - School of Medicine
New Orleans, Louisiana, 70112
United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Lee's Summit MO United States 64086
Lee's Summit, Missouri, 64086
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
United States
Kings Country Hospital Center
Brooklyn, New York, 11203
United States
David H. Koch Center at Memorial Sloan Kettering Cancer Center
New York, New York, 10021
United States
Duke University Medical Center - Division of Infectious Diseases
Durham, North Carolina, 27710
United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
United States
MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: AiCuris Anti-infective Cures AG

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-05-08
Study Completion Date2025-11-11

Study Record Updates

Study Start Date2017-05-08
Study Completion Date2025-11-11

Terms related to this study

Additional Relevant MeSH Terms

  • HSV Infection