drugset / Trial / NCT03073967
Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects
RandomizedParallel-groupOpen-labelTreatment
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 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).
Timeline
- Start
- 2017-05-08
- Primary completion
- 2025-08-15
- Completion
- 2025-11-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | CIDOFOVIR ANHYDROUS | Small molecule | 1 % | Intravenous |
| Comparator | CIDOFOVIR ANHYDROUS | Small molecule | 3 % | Intravenous |
| Comparator | CIDOFOVIR ANHYDROUS | Small molecule | 5 mg/kg | Intravenous |
| Comparator | Foscarnet | Small molecule | 40 mg/kg | Intravenous |
| Comparator | Foscarnet | Small molecule | 60 mg/kg | Intravenous |
| Comparator | Imiquimod | Other / unclassified | 5 % | Topical |
| Subject | Pritelivir | Small molecule | 100 mg | Oral |