Rezafungin for Treatment of Pneumocystis Pneumonia in HIV Adults
ConditionPneumocystis Pneumonia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMundipharma Research Limited
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Co-Trimoxazole
- Rezafungin Acetate / Co Trimoxazole
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov