Last updated on July 2018

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


Brief description of study

Randomized, open-label, multi-center, comparative trial to assess the efficacy and safety in immunocompromised subjects with acyclovir resistant mucocutaneous HSV infection, treated with pritelivir 100 mg qd (following a loading dose of 400 mg as first dose to rapidly reach steady-state plasma concentration) or foscarnet 40 mg/kg iv tid/60mg/kg iv bid.

Detailed Study Description

The Trial comprises 2 Parts, Part A and Part B.

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).

Pritelivir trial medication, in both Part A and Part B, will be given orally as single daily doses of 100 mg (following a loading dose of 400 mg as first dose) until 7 days after the mucocutaneous HSV lesions are healed or up to a maximum of 28 days, whichever is earlier.

Foscarnet, in Part A, will be given as intermittent infusions at a dose 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 until 7 days after the mucocutaneous HSV lesions are healed or up to a maximum of 28 days, whichever is earlier.

Clinical Study Identifier: NCT03073967

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Medpace

City of Hope National Medical Center
Duarte, CA United States
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Carly Sharp

Midway Immunology and Research Center (MIRC)
Fort Pierce, FL United States
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Angela Ristuccia

Comprehensive Care Center dba Community AIDs Network
Sarasota, FL United States
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Joan Lopez

Emory Hospital Midtown Infectious Disease Clinic
Atlanta, GA United States
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Jennifer Theusch

University of Chicago
Chicago, IL United States
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Paula Johnson

Indiana University (IU) Infectious Diseases Research
Indianapolis, IN United States
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Oyinkan Kusemiju

John Hopkins University School of Medicine
Baltimore, MD United States
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Medpace

Massachusetts General Hospital
Boston, MA United States
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Nicolas Issa

Brigham and Women's Hospital
Boston, MA United States
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Medpace

Wayne State University
Detroit, MI United States
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Katelyn Clark

Henry Ford Health System
Detroit, MI United States
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Medpace

Fred Hutchinson Cancer Research Center
Seattle, WA United States
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Rodolfo N. Molina, M.D.

Yale University School of Medicine - Infectious Diseases
New Haven, CT United States
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Meredith Marshall

Northwestern University
Chicago, IL United States
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Mieoak Bahk

Department of Medicine J. H. Stroger Hospital of Cook County
Chicago, IL United States
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Michael Augenbraun

SUNY Downstate Medical Center
Brooklyn, NY United States
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MD Anderson Cancer Center
Houston, TX United States
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Ashley Bader

Florida Health Sciences Center/Tampa General Hospital/USF
Tampa, FL United States
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Maximiliano Menna

Geogetown University Hospital
Washington, WA United States
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Jennifer Daigle

LSU Health Baton Rouge Pulmonary Clinic
Baton Rouge, LA United States
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