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

Description

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.

Study Start Date

May, 08 2017

Estimated Completion Date

September 2018

Interventions

  • Drug: Foscarnet
  • Drug: Pritelivir

Study ID

AiCuris Anti-infective Cures GmbH -- AIC316-03-II-01

Status

Recruiting

Trial ID

NCT03073967

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

30

Sponsor

AiCuris Anti-infective Cures GmbH

Inclusion Criteria

    1. Immunocompromised (due to conditions including HIV infection, hematopoietic-cell or solid organ transplantation, and chronic glucocorticoid use) men and women of any ethnic group aged ?18 years. 2. Acyclovir resistant mucocutaneous HSV infection based on clinical failure (no improvement after at least 5 days with FDA approved high doses with acyclovir, valacyclovir or famciclovir) requiring switch to foscarnet treatment. 3. Lesion accessible for size measurement and photography. 4. 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. 5. Ability to swallow tablets. 6. Willing to use non-hormonal birth control: Male subjects who are surgically sterile (eg, after vasectomy) or who must agree to use an adequate method of contraception during participation in the trial and for at least 1 complete month after the final dose of trial medication. Female subjects who are surgically sterile (eg, 2-sided tubal ligation, resection or ovariectomy, hysterectomy) or post-menopausal (defined as at least 50 years of age and who have a history of no menses for at least 24 months) or female subjects of childbearing potential with no male partner, or use an adequate method of contraception during participation in the trial and for at least 1 complete month after the final dose of trial medication. An adequate method of contraception is defined as one of the following acceptable birth control methods:
  • the use of the copper-releasing intrauterine device (to have been in place for at least 2 months prior to screening)
  • the use of one of the following: diaphragm, Lea's shield, FemCap, sponge, and
  • monogamous relationship with vasectomized partner
  • the use of a male condom during each act of sexual intercourse. 7. Subject must be willing and able (in the opinion of the investigator) to understand the informed consent form 8. Negative serum ? -HCG (beta human chorionic gonadotropin) test for female of child bearing potential at screening and a negative urine pregnancy test at randomization. 9. Subject must give written informed consent.

Exclusion Criteria

    1. Known intolerance to pritelivir and/or foscarnet or any of the excipients. 2. Need to use drugs that have a narrow therapeutic index and are substrates for CYP2B6, CYP2C8, CYP2C9, CYP2C19, OATP1B1, OATP1B3, and OCT1 (organic cation transporter 1), ie warfarin, digoxin, phenytoin, paclitaxel, S-mephenytoin 3. Baseline safety laboratory abnormalities: ANC (absolute neutrophil Count) < 1000 cells/mm3, platelet count < 25,000 cells/mm3, hemoglobin < 8.0 g/dL, AST (aspartate transaminase) or ALT (alanine transaminase) > 5 x ULN (upper Limit of normal), bilirubin > 2.5 x ULN 4. History or current evidence of gastrointestinal malabsorption which, in the opinion of the investigator, may affect the extent of absorption of pritelivir. 5. Severe renal insufficiency (GFR ? 29). 6. History or current evidence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric, or other diseases, which, in the opinion of the investigator, may affect the subject's safety or interfere with the trial. 7. Abnormalities in hematological, clinical chemical or any other laboratory variables at Screening measured by the central or local laboratory regarded as clinically relevant by the investigator unless they are due to underlying disease or condition. 8. Not able to communicate meaningfully with the Investigator and site staff. 9. Any other condition which in the opinion of the investigator would interfere with successful completion of this clinical trial. 10. Any other local condition including bacterial superinfection which in the opinion of the investigator would interfere with the efficacy evaluation. 11. Pregnant and/or breastfeeding women. 12. Having received an investigational drug in an investigational drug trial within the last 30 days before randomization for this clinical trial. Participation in a clinical trial without receiving other investigational drugs (e.g. follow-up phase of a trial, observational study) is permitted.

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (24)

Study Location Distance Name Phone Email
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles None None None
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles None None None
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles None None None
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles None None None
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
John Hopkins University School of Medicine - Baltimore, Maryland 356.0 miles None None None
Wayne State University - Detroit, Michigan 611.5 miles None None None
Henry Ford Health System - Detroit, Michigan 612.3 miles None None None
Indiana University IU Infectious Diseases Research - Indianapolis, Indiana 805.0 miles None None None
Indiana University IU Infectious Diseases Research - Indianapolis, Indiana 805.0 miles None None None
Indiana University IU Infectious Diseases Research - Indianapolis, Indiana 805.0 miles None None None
Indiana University IU Infectious Diseases Research - Indianapolis, Indiana 805.0 miles None None None
Indiana University IU Infectious Diseases Research - Indianapolis, Indiana 805.0 miles None None None
University of Chicago - Chicago, Illinois 848.0 miles None None None
Emory Hospital Midtown Infectious Disease Clinic - Atlanta, Georgia 935.3 miles None None None
Midway Immunology and Research Center MIRC - Fort Pierce, Florida 1,160.6 miles None None None
Midway Immunology and Research Center MIRC - Fort Pierce, Florida 1,160.6 miles None None None
Midway Immunology and Research Center MIRC - Fort Pierce, Florida 1,160.6 miles None None None
Midway Immunology and Research Center MIRC - Fort Pierce, Florida 1,160.6 miles None None None
Midway Immunology and Research Center MIRC - Fort Pierce, Florida 1,160.6 miles None None None
Comprehensive Care Center dba Community AIDs Network - Sarasota, Florida 1,223.9 miles None None None
Fred Hutchinson Cancer Research Center - Seattle, Washington 2,490.2 miles None None None
City of Hope National Medical Center - Duarte, California 2,578.2 miles None None None

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