Last updated on October 2017

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

Immunocompromised male or female subjects with acyclovir-resistant mucocutaneous HSV infection based on clinical failure requiring switch to foscarnet treatment. The acyclovir resistance status will be documented by genotypic testing, if the results from genotypic testing are negative or inconclusive phenotypic testing will be performed. Pritelivir trial medication will be given orally as single daily doses until 7 days after the mucocutaneous HSV lesions are healed or up to a maximum of 28 days, whichever is earlier. Foscarnet will be given as intermittent infusions at a dose of 40 mg/kg every 8 hours or 60mg/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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City of Hope National Medical Center
Duarte, CA United States
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Midway Immunology and Research Center (MIRC)
Fort Pierce, FL United States
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Comprehensive Care Center dba Community AIDs Network
Sarasota, FL United States
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Emory Hospital Midtown Infectious Disease Clinic
Atlanta, GA United States
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University of Chicago
Chicago, IL United States
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Indiana University (IU) Infectious Diseases Research
Indianapolis, IN United States
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John Hopkins University School of Medicine
Baltimore, MD United States
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Massachusetts General Hospital
Boston, MA United States
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Brigham and Women's Hospital
Boston, MA United States
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Wayne State University
Detroit, MI United States
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Henry Ford Health System
Detroit, MI United States
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Fred Hutchinson Cancer Research Center
Seattle, WA United States
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