Actively Recruiting
Rezafungin for Treatment of Pneumocystis Pneumonia in HIV Adults
Led by Mundipharma Research Limited · Updated on 2025-04-03
50
Participants Needed
6
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Rezafungin for Treatment of Pneumocystis Pneumonia in HIV Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 years or older
- Tested positive for HIV by approved blood tests
- Diagnosed with definitive, presumptive, or clinically suspected PCP before randomisation
- Willing and able to provide written informed consent or have a legal representative provide consent
- Female participants of childbearing potential must agree to use effective contraception during the study and for 30 days after last dose of rezafungin
- Biologically male participants not vasectomised must agree to refrain from donating sperm and use contraception or abstain from sexual intercourse with females of childbearing potential during the study and for 120 days after last dose
You will not qualify if you...
- Under 18 years of age
- Known or suspected allergy to co-trimoxazole, rezafungin, echinocandins, or formulation components
- Contraindications to co-trimoxazole or medications that severely interact with it
- Severe kidney impairment or on renal replacement therapy
- Severe liver impairment or history of chronic cirrhosis
- Low neutrophil count (<1,000 cells/µL) or low platelet count (<50,000 cells/µL)
- Immunosuppressive diseases other than HIV/AIDS or recent use of immune-weakening medications
- Previous PCP treatment in the past 6 weeks
- Receiving approved PCP therapy for more than 48 hours before randomisation (except prophylactic doses)
- Moderate to severe neurological conditions including ataxia, tremors, neuropathy, multiple sclerosis, or movement disorders
- Planned or ongoing therapy with certain neurotoxic medications
- Previous participation in any rezafungin study
- Pregnant or lactating females
- Any medical condition or disease that poses undue risk, impedes study completion, or compromises study validity
- Participation in other investigational drug or device studies within 30 days prior to dosing
- Investigator's opinion that participant should not take part
- Participants without confirmed PCP diagnosis on Day 8 based on specific microbiological and radiographic criteria
AI-Screening
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Trial Site Locations
Total: 6 locations
1
University of Cape Town
Cape Town, South Africa
Actively Recruiting
2
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, South Africa
Actively Recruiting
3
Helen Joseph Hospital
Johannesburg, South Africa
Terminated
4
Global Clinical Trials - Pretoria
Pretoria, South Africa
Actively Recruiting
5
Steve Biko Academic Hospital
Pretoria, South Africa
Actively Recruiting
6
Netcare Umhlanga Medical Centre
Umhlanga, South Africa
Actively Recruiting
Research Team
E
Elizabeth Chong, MSc
CONTACT
T
Terry Nichols
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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