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

  • STATUS
    Recruiting
  • End date
    Mar 21, 2024
  • participants needed
    128
  • sponsor
    AiCuris Anti-infective Cures GmbH
Updated on 21 November 2021
diabetes
vasectomy
renal function
HIV Infection
organ transplantation
foscarnet
tingling
copper
neutropenia
valacyclovir
acyclovir
granulocytopenia
famciclovir
pritelivir

Summary

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 foscarnet 40 mg/kg every 8 hours or 60 mg/kg every 12 hours.

Description

The trial comprises 5 Parts, Part A, B, C, D and E. Part A and Part B (Phase 2) have been closed in November 2020.

  • 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).

Parts C, D and E (Phase 3) are currently being set-up.

  • Part C is a randomized, open-label, multi-center, comparative design to assess the efficacy and safety of oral pritelivir in subjects with acyclovir resistent (ACV-R) mucocutaneous HSV episodes. Subjects with ACV-R mucocutaneous HSV infection will be randomized 1:1 to receive either oral pritelivir or iv foscarnet. The trial is designed to show superiority of pritelivir against foscarnet in obtaining clinical cure, i.e. number of subjects with all lesions healed within 28 days.
  • Part D is an open-label, multi-center (performed in the same trial sites as Part C) design to assess the efficacy and safety of pritelivir in subjects with ACV-R mucocutaneous HSV episodes and who in addition either:
    1. present with foscarnet resistance/intolerance already at Screening for inclusion, or
    2. developed foscarnet resistance/intolerance during treatment in Part C (no improvement after at least 7 days of foscarnet treatment or intolerance to foscarnet requiring cessation of foscarnet treatment).
  • Part E is an open-label, multi-center (performed in the same trial sites as Part C) design to assess the safety and efficacy of pritelivir in subjects with acyclovir susceptible (ACV-S) mucocutaneous HSV episodes.

Pritelivir trial medication will be given orally as single daily doses of 100 mg (following a loading dose of 400 mg as first dose) until all mucocutaneous HSV lesions are healed or up to 28 days, whichever is earlier. A prolongation up to a maximum of 42 days may be possible.

Foscarnet 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 all mucocutaneous HSV lesions are healed or up to 28 days, whichever is earlier. A prolongation up to a maximum of 42 days may be possible.

Details
Condition Herpes Simplex, HSV Infection
Treatment Pritelivir, Foscarnet, Foscarnet
Clinical Study IdentifierNCT03073967
SponsorAiCuris Anti-infective Cures GmbH
Last Modified on21 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Immunocompromised men and women of any ethnic group aged 16 years
ACV-R mucocutaneous HSV infection based on clinical failure requiring switch to foscarnet treatment or positive ACV resistance testing for current lesion
Lesions accessible for visual inspection to allow assessment of lesion healing including visualization by endoscopy or pharyngoscopy
Willingness to abstain from the application of lotions and/or creams to the area with HSV lesions. Wet/dry saline dressings or bandages at lesion site are allowed
Willingness to use highly effective birth control
Subject, and/or their legally authorized representative, must be willing and able to understand the Informed Consent Form
Negative serum -HCG (beta-human chorionic gonadotropin) test for women of child-bearing potential at Screening and a negative urine pregnancy test at Day 1
Written informed consent. For subjects, who are unable to provide informed consent for whatever reason, written consent must be obtained from the legal representative
Part D inclusion criteria
All inclusion criteria as for Part C, except for inclusion criterion 2, which
\. ACV-R and foscarnet-R mucocutaneous HSV infection based on clinical failure or positive genotypic/phenotypic resistance testing for current lesion or documented intolerance to foscarnet requiring cessation of foscarnet treatment or precluding foscarnet treatment
Part E inclusion criteria
All inclusion criteria as for Part C, except for inclusion criterion 2, which
is replaced
is replaced
by
by
\. Recurrent mucocutaneous HSV infection considered ACV-S

Exclusion Criteria

Known resistance/intolerance to pritelivir and/or foscarnet or any of the excipients
Previous treatment in PRIOH-1
Need to use warfarin, phenytoin, paclitaxel
Baseline safety laboratory abnormalities
History or current evidence of gastrointestinal malabsorption which, in the opinion of the Investigator, may affect the extent of absorption of pritelivir
Severe renal insufficiency (eGFR 29)
History or current evidence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric, or other relevant diseases
Abnormalities in hematological, clinical chemical or any other laboratory variables
Any other condition which in the opinion of the Investigator would interfere with successful completion of this clinical trial
Any other important local condition
Having received an investigational drug in an investigational drug trial unter certain conditions
Part D exclusion criteria
Not able to communicate meaningfully with the Investigator and site staff
All exclusion criteria as for Part C, except for exclusion criterion 1, which
is replaced
by
Pregnant and/or breastfeeding women
Known intolerance to pritelivir or any of the excipients and except criterion 13, which is replaced by: 13. Having received an investigational drug in an investigational drug within 7 half-lives after the last administration of this drug before initiating trial medication, except for subjects entering Part D, who have previously received foscarnet treatment in Part C of this trial
Participation in a clinical trial without receiving other investigational
drugs (eg, follow-up phase of a trial, observational study) is permitted
Part E exclusion criteria
All exclusion criteria as for Part C, except for exclusion criteria 1, which
is replaced by known intolerance to pritelivir or any of the excipients and
Having used (val)acyclovir within 3 days prior to starting pritelivir
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