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

Launched by AICURIS ANTI-INFECTIVE CURES AG · Mar 3, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called pritelivir to see how effective and safe it is for treating herpes simplex virus (HSV) infections in people with weakened immune systems. These individuals may not respond to standard treatments like acyclovir, and the trial aims to offer them a better option. Participants will take pritelivir once daily after an initial higher dose to quickly reach the right level in their blood. There are also other treatment options allowed in the study, depending on what the doctor thinks is best.

To join this trial, participants must be at least 16 years old and have a specific type of HSV infection that is resistant to acyclovir, which means previous treatments haven't worked. They should also have visible lesions that can be monitored for healing. Women who can become pregnant will need to use effective birth control and have negative pregnancy tests before starting the trial. Participants can expect regular check-ins to monitor their health and the effectiveness of the treatment. This trial is currently recruiting patients, and it's important for those interested to discuss with their doctor to see if they meet the eligibility criteria.

Gender

ALL

Eligibility criteria

• • Part C inclusion criteria
• • 1. Immunocompromised men and women of any ethnic group aged ≥16 years.
• In Canada, Germany, Belgium:
• • Immunocompromised (due to conditions including but not limited to HIV infection, hematopoietic cell or solid organ transplantation, and chronic use of immunosuppressive treatment) men and women of any ethnic group aged \>18 years.
• • 2. ACV-R mucocutaneous HSV infection based on clinical failure or positive genotypic/phenotypic ACV resistance testing for current lesion. Clinical failure is defined as no improvement after oral or iv doses for at least 7 days at doses equivalent to or greater than the local agency approved high oral doses of acyclovir, valacyclovir or famciclovir.
• • 3. Lesions accessible for visual inspection to allow assessment of lesion healing including visualization by endoscopy.
• • 4. Willingness to use highly effective birth control.
• • 5. Subject, and/or their legally authorized representative, (proxy consent is not permitted in Germany), must be willing and able to understand the Informed Consent Form.
• • 6. Negative serum β-HCG (beta-human chorionic gonadotropin) test for women of child-bearing potential at Screening and a negative urine pregnancy test at Day 1.
• • 7. Written informed consent. For subjects, who are unable to provide informed consent for whatever reason, written consent must be obtained from the legal representative, (proxy consent is not permitted in Germany).
• • Part D and F inclusion criteria
• All inclusion criteria as for Part C, except for inclusion criterion 2, which is replaced by:
• • 2. 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 iv foscarnet requiring cessation of foscarnet treatment or precluding foscarnet treatment.
• • Subjects will be able to enter Part F only after closure of enrollment in Part D.
• • Part E inclusion (Part E is not being conducted in Germany)
• All inclusion criteria as for Part C, except for inclusion criterion 2, which is replaced by:
• • 2. Recurrent mucocutaneous HSV infection considered ACV-S.
• • Part C exclusion criteria
• • 1. Known resistance/intolerance to pritelivir or any of the excipients.
• • 2. Previous treatment in PRIOH-1.
• • 3. Baseline safety laboratory abnormalities.
• • 4. History or current evidence of gastrointestinal malabsorption which, in the opinion of the Investigator, may affect the extent of absorption of pritelivir.
• • 5. Hemodialysis for any indication and ESRD (eGFR \<15 mL/min; stage 5 CKD)
• • 6. History or current evidence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric, or other relevant diseases.
• • 7. Abnormalities in hematological, clinical chemical or any other laboratory variables.
• • 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 important local condition.
• • 11. Pregnant and/or breastfeeding women.
• • 12. Having received an investigational drug in an investigational drug trial unter certain conditions.
• • Part D (complete) exclusion criteria
• All exclusion criteria as for Part C, except criterion 12, which is replaced by:
• • 13. Having received an investigational drug in an investigational trial 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 (Part E is not being conducted in Germany)
• All exclusion criteria in Part E are identical to those in Part C with the addition of:
• • 13. Having used acyclovir, valacyclovir, or famciclovir within 3 days prior to starting pritelivir.
• • Part F exclusion criteria All exclusion criteria for Part D plus 13. Part D open for enrollment