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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT03073967

Public ClinicalTrials.gov record NCT03073967. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 4:43 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT03073967
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
AiCuris Anti-infective Cures AG
Industry
Enrollment
158 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
16 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 8, 2017 (Actual)
Primary completion
Aug 15, 2025 (Actual)
Completion
Nov 11, 2025 (Actual)
Last update posted
Jun 12, 2026

2017 – 2025

United States locations

U.S. sites
33
U.S. states
19
U.S. cities
33
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35205 —
Metro Infectious Disease Consultants, LLC - Huntsville Huntsville Alabama 35801 —
University of South Alabama Mobile Alabama 36604 —
University Arizona - Department of Medicine Arizona Health Sciences Center Tucson Arizona 85724 —
City of Hope Duarte California 91010 —
Cedars-Sinai Medical Center Los Angeles California 90048 —
University of California, Division of Infectious Diseases Sacramento California 95817 —
Midland Florida Clinical Research Center, LLC DeLand Florida 32720 —
Midway Immunology and Research Center (MIRC) Ft. Pierce Florida 34982 —
University of Florida (UF) - Division of Infectious Disease Gainesville Florida 32610 —
Links Clinical Trials Miami Florida 33176 —
University of South Florida Tampa Florida 33606 —
Emory Hospital Midtown Infectious Disease Clinic Atlanta Georgia 30308 —
Metro Infectious Disease Consultants - Atlanta Decatur Georgia 30033 —
Metro Infectious Disease Consultants, LLC Burr Ridge Illinois 60527 —
Department of Medicine J. H. Stroger Hospital of Cook County Chicago Illinois 60612 —
LSU Health Baton Rouge Pulmonary Clinic Baton Rouge Louisiana 70809 —
Tulane University - School of Medicine New Orleans Louisiana 70112 —
Johns Hopkins University School of Medicine Baltimore Maryland 21205 —
Brigham and Women's Hospital Boston Massachusetts 02115 —
University of Minnesota Minneapolis Minnesota 55455 —
Lee's Summit MO United States 64086 Lee's Summit Missouri 64086 —
University of Nebraska Medical Center Omaha Nebraska 68198 —
Rutgers Robert Wood Johnson Medical School New Brunswick New Jersey 08901 —
Kings Country Hospital Center Brooklyn New York 11203 —
David H. Koch Center at Memorial Sloan Kettering Cancer Center New York New York 10021 —
Duke University Medical Center - Division of Infectious Diseases Durham North Carolina 27710 —
Atrium Health Wake Forest Baptist Winston-Salem North Carolina 27157 —
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 —
Penn State Health Milton S. Hershey Medical Center Hershey Pennsylvania 17033 —
University of Pittsburgh Medical Center Pittsburgh Pennsylvania 15232 —
MD Anderson Cancer Center Houston Texas 77030-4009 —
Fred Hutchinson Cancer Research Center Seattle Washington 98109 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 37 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03073967, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 12, 2026 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03073967 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →