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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 2 trial, which means it's still in an early stage of testing rezafungin for PCP — what does that mean for how much we already know about whether it's safe and effective compared to the standard treatment I'd normally receive?
2The trial is measuring 'therapeutic failure' by Day 8, which is pretty early in treatment — does that timeline align with how quickly my current infection needs to respond, and what would happen if I'm not improving by then?
3Since this trial is specifically for HIV-positive adults with Pneumocystis pneumonia, how does my overall HIV status and CD4 count affect whether this kind of experimental treatment might be a reasonable option for me to discuss?
4Is there an established standard-of-care treatment for PCP that I should consider first before exploring an experimental drug like rezafungin, and how would my doctor weigh those two paths given where my illness stands right now?
5If I enroll and rezafungin doesn't seem to be working, what is the plan for switching me to proven treatments quickly enough to protect my health?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.