Rezafungin for Treatment of Pneumocystis Pneumonia in HIV Adults (NCT05835479) | Clinical Trial Compass
RecruitingPhase 2
Rezafungin for Treatment of Pneumocystis Pneumonia in HIV Adults
South Africa50 participantsStarted 2023-11-14
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Males or females at least 18 years of age.
✓. Tested positive for HIV by either blood antigen/antibody combination HIV-1/2 immunoassay, HIV-1/HIV-2 antibody differentiation immunoassay, or nucleic acid tests (e.g., HIV ribonucleic acid \[RNA\] polymerase chain reaction \[PCR\]). Participants who are newly diagnosed with HIV infection by an antigen/antibody combination HIV-1/2 immunoassay are allowed to be included in the study, but the infection should be subsequently confirmed by an HIV-1/HIV-2 antibody differentiation immunoassay or nucleic acid tests.
✓. Diagnosed with definitive, presumptive, or clinically suspected PCP prior to randomisation.
✓. Willing and able to provide written informed consent. If the participant is unable to provide consent, a legally acceptable representative (i.e., acceptable to ICH and local law, as applicable) must provide informed consent on the participant's behalf.
✓. Participants of childbearing potential (all biologically female participants between 18 years and \<2 years post-menopausal unless surgically sterile) must agree to use a highly effective contraceptive measure during the study period (from enrolment) and for at least 30 days after the last dose of rezafungin.
✓. Biologically male participants who are not vasectomised must agree to the following requirements during the study period (from enrolment) and for at least 120 days after the last dose of rezafungin:
Exclusion criteria
✕. Under 18 years of age.
✕. Known or suspected hypersensitivity or allergic reaction to co-trimoxazole, rezafungin, any echinocandin, or any component of these formulations, including, but not limited to, anaphylaxis or exfoliative skin disorders (e.g., Stevens-Johnson syndrome or toxic epidermal necrolysis).
✕. Any contraindication to co-trimoxazole or intake of a medication or supplement known to severely interact with co-trimoxazole as detailed in the Summary of Product Characteristics (SmPC) of co-trimoxazole, including, but not limited to, acute porphyria or a history of drug-induced immune thrombocytopaenia with use of trimethoprim and/or sulphonamides.
✕. Creatinine clearance \<15 mL/min or receiving renal replacement therapy.
✕. Severe hepatic impairment, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>5 × upper limits of normal (ULN), or total bilirubin \>3 × ULN, or a history of chronic cirrhosis (Child-Pugh score \>9).
✕. A neutrophil count \<1,000 cells/µL or a platelet count \<50,000 cells/µL.
✕. Immunosuppressive disease other than HIV / acquired immunodeficiency syndrome (AIDS) (e.g., haematopoietic stem cell transplant, solid organ transplant, or primary immune deficiencies) OR prolonged use of immune-weakening medications:
✕. Previously diagnosed with PCP and having received treatment in the past 6 weeks.