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 who are diagnosed with definitive, presumptive, or clinically suspected PCP 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.
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.