Pneumocystis PneumoniaPhase 2NCT05835479
Rezafungin for Treatment of Pneumocystis Pneumonia in HIV Adults
A Phase 2 study testing Co-Trimoxazole and Rezafungin Acetate / Co Trimoxazole in people with Pneumocystis Pneumonia, run by Mundipharma Research Limited at 6 sites in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumocystis Pneumonia
- What is being tested?
- Co-Trimoxazole and Rezafungin Acetate / Co Trimoxazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 6 sitesSouth Africa
- Study dates
- 14 Nov 2023to Aug 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- Refrain from donating sperm PLUS, either
- Abstain from sexual intercourse with a female of childbearing potential as their preferred and usual lifestyle OR
- Use barrier contraception (i.e., male condom with or without spermicide) when having sexual intercourse with a female of childbearing potential who is not currently pregnant.
Who cannot join
- 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.
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- 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:
- Having received corticosteroids equivalent to prednisone ≥20 mg daily for at least 14 consecutive days within 30 days prior to study entry, or
- Having received biologics (e.g., infliximab, ustekinumab), immunomodulators (e.g., methotrexate, mercaptopurine, azathioprine), or cancer chemotherapy within 90 days prior to study entry.
- Previously diagnosed with PCP and having received treatment in the past 6 weeks.
- Receiving therapy for PCP at approved therapeutic doses for >48 hours before randomisation. Exception: receipt of an anti-PCP drug at prophylactic doses (i.e., lower than approved therapeutic doses).
- Meeting National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 criteria for ataxia, tremors, motor neuropathy, or sensory neuropathy of Grade 2 or higher.
- History of severe ataxia, tremors, or neuropathy or a diagnosis of multiple sclerosis or a movement disorder (including Parkinson's disease and Huntington's disease).
- Planned or ongoing therapy at Screening with a known severe neurotoxic medication or with a known moderate neurotoxic medication in a participant with ataxia, tremors, motor neuropathy, or sensory neuropathy of NCI-CTCAE version 5.0 Grade 1 or higher.
- Previous participation in this or any other rezafungin study.
- Female participants who are pregnant or lactating.
- Having a concomitant disease or any medical condition (including other HIV-associated infection or complication) that, in the opinion of the Investigator, could pose undue risk to the participant, impede completion of the study procedures (e.g., patients who are not expected to survive even with treatment), or would compromise the validity of the study measurements.
- Receipt of an investigational drug within 30 days prior to dosing of the study drug(s), presence of an investigational device at the time of Screening, or is planning to participate in another interventional clinical study while enrolled in this study.
- The Investigator is of the opinion the participant should not participate in the study.
- Late Exclusion Criteria:
- The diagnosis of PCP will be reviewed by the Investigator on Day 8 (before dosing the study drug). Participants will be withdrawn from the study if any of the following criteria apply (i.e., participants without a diagnosis of definitive or presumptive PCP on Day 8):
- Lack of positive P. jirovecii immunofluorescence or PCR of bronchoalveolar lavage, endotracheal aspirates, bronchoscopic tissue biopsy, or induced sputum AND serum β-D-glucan below the positive cut-off value.
- Serum β-D-glucan below the positive cut-off value in participants in whom collection of a suitable respiratory sample is not possible.
- Radiographic features on chest CT performed after randomisation not consistent with PCP after taking into account the clinical and microbiological findings.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Terry Nichols contact
6 sites in 1 country
South Africa6 sites, 5 recruiting
- Recruiting
University of Cape Town
Cape Town
Dr Schutz
- Recruiting
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg
Dr Shaddock
- Terminated
Helen Joseph Hospital
Johannesburg
- Recruiting
Global Clinical Trials - Pretoria
Pretoria
Dr Pillay-Ramaya
- Recruiting
Steve Biko Academic Hospital
Pretoria
Dr Ueckermann
- Recruiting
Netcare Umhlanga Medical Centre
Umhlanga
Dr Sarvan
About this study
Official title: A Phase 2, Proof-of-Concept, Multicentre, Open-Label, Randomised, Active-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rezafungin Combined With 7 Days of Co-Trimoxazole Versus Co-Trimoxazole Monotherapy in HIV-Infected Adults With Pneumocystis Jirovecii Pneumonia
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.
Read the detailed description
The study comprises a Screening period from Day -2 to Day -1, a Treatment period from Day 1 to Day 21, and a Follow-up visit on Day 50 (±2 days). The total duration for the study will be up to approximately 52 days.
Participants meeting the eligibility criteria will be randomised in a 1:1 ratio to either the rezafungin/co-trimoxazole group or co-trimoxazole monotherapy group. Randomisation will be stratified by disease severity into two categories (mild or moderate-to-severe).
After completion of the 21-day treatment, co-trimoxazole for secondary prophylaxis against P. jirovecii will be given to all participants. In participants who are discovered to have an allergy or intolerance to co-trimoxazole during the study, an alternative secondary prophylaxis will be provided as per local practice and treatment guidelines, decided by the treating physician. Participants will have a Follow-up visit on Day 50 (±2 days) to evaluate AEs, treatment response, and rates of PCP relapse or paradoxical IRIS (Immune reconstitution inflammatory syndrome).
Participants will be monitored for AEs from the time the first dose of the study drugs is administered to the Follow-up visit on Day 50 (±2 days). Additional safety assessments including vital signs, safety laboratory evaluations (haematology, serum chemistry panel, and urinalysis), physical examinations (complete and symptom-directed), and 12-lead ECGs will also be assessed. Prior and concomitant medications will be recorded.
- Conditions
- Pneumocystis Pneumonia
- Being tested
- Co-Trimoxazole, Rezafungin Acetate / Co Trimoxazole
- Medical subject headings
- Pneumonia, Pneumocystis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-TrimoxazoleDrug
Oral co-trimoxazole or Intravenous (IV) co-trimoxazole for infusion. Anti fungal medication
Rezafungin Acetate / Co TrimoxazoleDrug
Rezafungin for infusion. Intravenous anti fungal therapy
Oral co-trimoxazole or Intravenous (IV) co-trimoxazole for infusion. Anti fungal medication
| Study group | Role | What they receive |
|---|---|---|
| Rezafungin Acetate /Co-trimoxazole | Experimental | Rezafungin: Weekly intravenous infusion with a loading dose of 400 mg over 1 hour (±10 minutes) on Day 1 followed by maintenance doses of 200 mg over 1 hour (±10 minutes) on Day 8 and Day 15.
From Day 1 to Day 7, co-trimoxazole will also be given with trimethoprim 15-20 mg/kg/day and sulfamethoxazole 75-100 mg/kg/day.
For participants with a creatinine clearance between 15 mL/min and 30 mL/min, the dose of co-trimoxazole should be reduced to trimethoprim 7.5-10 mg/kg/day and sulfamethoxazole 37.5-50 mg/kg/day Receives: Drug: Rezafungin Acetate / Co Trimoxazole |
| Co-trimoxazole | Active comparator | From Day 1 to Day 21, co-trimoxazole will be given with trimethoprim 15-20 mg/kg/day and sulfamethoxazole 75-100 mg/kg/day.
For participants with a creatinine clearance between 15 mL/min and 30 mL/min, the dose of co-trimoxazole should be reduced to trimethoprim 7.5-10 mg/kg/day and sulfamethoxazole 37.5-50 mg/kg/day Receives: Drug: Co-Trimoxazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic failure on Day 8
Therapeutic failure on Day 8, defined by one of the following and confirmed by an independent, blinded Data Review Committee (DRC):
- Clinical deterioration. The deterioration cannot be solely explained by other infections or causes and is defined as an increase in score of 2 points or more from the score prior to randomisation on Day 1 on the Ordinal Scale for Clinical Improvement (OSCI), as assessed by the Investigator.
- Requirement for alternative primary therapy for PCP, or intensification of corticosteroid therapy, due to lack of efficacy (as assessed by the Investigator).
- Death from any cause.
Measured: 8 days
Secondary outcomes (1)
Therapeutic failure at any time during the treatment period (from Day 1 to Day 21)
Therapeutic failure at any time during the treatment period (from Day 1 to Day 21) defined by one of the following and confirmed by an independent, blinded Data Review Committee (DRC):
- Clinical deterioration. The deterioration cannot be solely explained by other infections or causes and is defined as an increase in score of 2 points or more from the score prior to randomisation on Day 1 on the Ordinal Scale for Clinical Improvement (OSCI), as assessed by the Investigator.
- Requirement for alternative primary therapy for PCP, or intensification of corticosteroid therapy, due to lack of efficacy (as assessed by the Investigator).
- Death from any cause.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start14 Nov 2023
- Primary completionMay 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pneumocystis PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mundipharma Research Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohit Joshi, MD, Study director, Mundipharma Research Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835479
- Sponsor's protocol ID
- MR907-2501
- Status last verified
- Apr 2025
- First submitted
- 4 Apr 2023
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Peghin M, Fishman JA, Grossi PA. Pneumocystis jiroveci : still troublesome to diagnose and treat. Curr Opin Infect Dis. 2025 Dec 1;38(6):522-529. doi: 10.1097/QCO.0000000000001155. Epub 2025 Oct 17.
PubMed 41151592
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Proof-of-Concept, Multicentre, Open-Label, Randomised, Active-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rezafungin Combined With 7 Days of Co-Trimoxazole Versus Co-Trimoxazole Monotherapy in HIV-Infected Adults With Pneumocystis Jirovecii Pneumonia
- ClinicalTrials.gov ID
- NCT05835479
- Acronym / sponsor ID
- MR907-2501
- Conditions
- Pneumocystis Pneumonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mundipharma Research LimitedIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study comprises a Screening period from Day -2 to Day -1, a Treatment period from Day 1 to Day 21, and a Follow-up visit on Day 50 (±2 days). The total duration for the study will be up to approximately 52 days.
Participants meeting the eligibility criteria will be randomised in a 1:1 ratio to either the rezafungin/co-trimoxazole group or co-trimoxazole monotherapy group. Randomisation will be stratified by disease severity into two categories (mild or moderate-to-severe).
After completion of the 21-day treatment, co-trimoxazole for secondary prophylaxis against P. jirovecii will be given to all participants. In participants who are discovered to have an allergy or intolerance to co-trimoxazole during the study, an alternative secondary prophylaxis will be provided as per local practice and treatment guidelines, decided by the treating physician. Participants will have a Follow-up visit on Day 50 (±2 days) to evaluate AEs, treatment response, and rates of PCP relapse or paradoxical IRIS (Immune reconstitution inflammatory syndrome).
Participants will be monitored for AEs from the time the first dose of the study drugs is administered to the Follow-up visit on Day 50 (±2 days). Additional safety assessments including vital signs, safety laboratory evaluations (haematology, serum chemistry panel, and urinalysis), physical examinations (complete and symptom-directed), and 12-lead ECGs will also be assessed. Prior and concomitant medications will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rezafungin Acetate /Co-trimoxazole | Experimental | Drug: Rezafungin Acetate / Co TrimoxazoleRezafungin: Weekly intravenous infusion with a loading dose of 400 mg over 1 hour (±10 minutes) on Day 1 followed by maintenance doses of 200 mg over 1 hour (±10 minutes) on Day 8 and Day 15. From Day 1 to Day 7, co-trimoxazole will also be given with trimethoprim 15-20 mg/kg/day and sulfamethoxazole 75-100 mg/kg/day. For participants with a creatinine clearance between 15 mL/min and 30 mL/min, the dose of co-trimoxazole should be reduced to trimethoprim 7.5-10 mg/kg/day and sulfamethoxazole 37.5-50 mg/kg/day |
| Co-trimoxazole | Active comparator | Drug: Co-TrimoxazoleFrom Day 1 to Day 21, co-trimoxazole will be given with trimethoprim 15-20 mg/kg/day and sulfamethoxazole 75-100 mg/kg/day. For participants with a creatinine clearance between 15 mL/min and 30 mL/min, the dose of co-trimoxazole should be reduced to trimethoprim 7.5-10 mg/kg/day and sulfamethoxazole 37.5-50 mg/kg/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (24 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Co-TrimoxazoleOral co-trimoxazole or Intravenous (IV) co-trimoxazole for infusion. Anti fungal medication | Drug | Co-trimoxazole |
| Rezafungin Acetate / Co TrimoxazoleRezafungin for infusion. Intravenous anti fungal therapy Oral co-trimoxazole or Intravenous (IV) co-trimoxazole for infusion. Anti fungal medication | Drug | Rezafungin Acetate /Co-trimoxazole |
Primary outcome
Therapeutic failure on Day 8
Time frame: 8 days
Therapeutic failure on Day 8, defined by one of the following and confirmed by an independent, blinded Data Review Committee (DRC): * Clinical deterioration. The deterioration cannot be solely explained by other infections or causes and is defined as an increase in score of 2 points or more from the score prior to randomisation on Day 1 on the Ordinal Scale for Clinical Improvement (OSCI), as assessed by the Investigator. * Requirement for alternative primary therapy for PCP, or intensification of corticosteroid therapy, due to lack of efficacy (as assessed by the Investigator). * Death from any cause.
1 secondary outcome
Therapeutic failure at any time during the treatment period (from Day 1 to Day 21)
Time frame: 21 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Derived from this study: PubMed 41151592Peghin M, Fishman JA, Grossi PA. Pneumocystis jiroveci : still troublesome to diagnose and treat. Curr Opin Infect Dis. 2025 Dec 1;38(6):522-529. doi: 10.1097/QCO.0000000000001155. Epub 2025 Oct 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Terry Nichols contact
Mohit Joshi, MD study director
Mundipharma Research Limited
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Co-Trimoxazole and Rezafungin Acetate / Co Trimoxazole in people with Pneumocystis Pneumonia, run by Mundipharma Research Limited at 6 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Chong, MSc (+441223424900, Clinicaltrialsinfo@mundipharma-rd.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic failure on Day 8 (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05835479, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.