Phase 2 Study Comparing Rezafungin Plus 7 Days of Co-Trimoxazole Versus Co-Trimoxazole Alone for Treating Pneumocystis Pneumonia in Adults with HIV

What this Trial Is About

This research aims to evaluate the effectiveness, safety, and tolerability of rezafungin combined with 7 days of co-trimoxazole compared to co-trimoxazole alone for treating Pneumocystis pneumonia PCP in adults living with HIV. The study is a Phase 2, open-label, randomized trial designed to expand knowledge about the clinical use of rezafungin in this population. Participants are adults diagnosed with definitive, presumptive, or clinically suspected PCP and living with HIV. The study includes a Screening period from Day -2 to Day -1, a Treatment period from Day 1 to Day 21, and a Follow-up visit around Day 50. Participants are randomly assigned to one of two groups one group receives weekly intravenous rezafungin infusions on Days 1, 8, and 15 combined with 7 days of oral or IV co-trimoxazole, while the other group receives co-trimoxazole alone for 21 days. Dosing adjustments for co-trimoxazole are made for participants with reduced kidney function. After the treatment period, all participants receive secondary prophylaxis against PCP following local guidelines. Throughout the study, participants will be monitored for adverse events and treatment response, including the rates of PCP relapse or immune reconstitution inflammatory syndrome. Safety assessments include vital signs, laboratory tests blood counts, chemistry, urinalysis, physical exams, and heart monitoring with ECGs. Medication use will be recorded. The total participation duration is approximately 52 days, ending with a follow-up visit to evaluate outcomes and safety.

Rezafungin for Treatment of Pneumocystis Pneumonia in HIV Adults