Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects
Completed · Phase 3
Conditions studied: HSV Infection
In brief
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).
Key facts
- Study ID
- NCT03073967
- Run by
- AiCuris Anti-infective Cures AG
- People needed
- 158
- Starts
- 2017-05-08
- Expected to finish
- 2025-11-11
- Last updated by the study team
- 2026-06-12
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Metro Infectious Disease Consultants, LLC - Huntsville — Huntsville, Alabama, United States
- University of South Alabama — Mobile, Alabama, United States
- University Arizona - Department of Medicine Arizona Health Sciences Center — Tucson, 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
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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