NCT05835479

Rezafungin for Treatment of Pneumocystis Pneumonia in HIV Adults

A Phase 2, Proof-of-Concept, Multicentre, Open-Label, Randomised, Active-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rezafungin Combined With 7 Days of Co-Trimoxazole Versus Co-Trimoxazole Monotherapy in HIV-Infected Adults With Pneumocystis Jirovecii Pneumonia

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Mundipharma Research Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to generate clinical data on the efficacy, safety, and tolerability of rezafungin combined with 7 days of co-trimoxazole for treatment of Pneumocystis pneumonia (PCP) in adults living with human immunodeficiency virus (HIV), which would expand the knowledge of clinical use of rezafungin.

Detailed description

The study comprises a Screening period from Day -2 to Day -1, a Treatment period from Day 1 to Day 21, and a Follow-up visit on Day 50 (±2 days). The total duration for the study will be up to approximately 52 days. Participants meeting the eligibility criteria will be randomised in a 1:1 ratio to either the rezafungin/co-trimoxazole group or co-trimoxazole monotherapy group. Randomisation will be stratified by disease severity into two categories (mild or moderate-to-severe). After completion of the 21-day treatment, co-trimoxazole for secondary prophylaxis against P. jirovecii will be given to all participants. In participants who are discovered to have an allergy or intolerance to co-trimoxazole during the study, an alternative secondary prophylaxis will be provided as per local practice and treatment guidelines, decided by the treating physician. Participants will have a Follow-up visit on Day 50 (±2 days) to evaluate AEs, treatment response, and rates of PCP relapse or paradoxical IRIS (Immune reconstitution inflammatory syndrome). Participants will be monitored for AEs from the time the first dose of the study drugs is administered to the Follow-up visit on Day 50 (±2 days). Additional safety assessments including vital signs, safety laboratory evaluations (haematology, serum chemistry panel, and urinalysis), physical examinations (complete and symptom-directed), and 12-lead ECGs will also be assessed. Prior and concomitant medications will be recorded.

Conditions

• Pneumocystis Pneumonia

Interventions

Type	Name	Description
DRUG	Co-Trimoxazole	Oral co-trimoxazole or Intravenous (IV) co-trimoxazole for infusion. Anti fungal medication
DRUG	Rezafungin Acetate / Co Trimoxazole	Rezafungin for infusion. Intravenous anti fungal therapy Oral co-trimoxazole or Intravenous (IV) co-trimoxazole for infusion. Anti fungal medication

Timeline

• Start date: 2023-11-14
• Primary completion: 2025-05-01
• Completion: 2025-08-01
• First posted: 2023-04-28
• Last updated: 2025-04-03

Locations

6 sites across 1 country: South Africa