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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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:

‣ 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.

Locations
Other Locations
South Africa
University of Cape Town
RECRUITING
Cape Town
Charlotte Maxeke Johannesburg Academic Hospital
RECRUITING
Johannesburg
Helen Joseph Hospital
TERMINATED
Johannesburg
Global Clinical Trials - Pretoria
RECRUITING
Pretoria
Steve Biko Academic Hospital
RECRUITING
Pretoria
Netcare Umhlanga Medical Centre
RECRUITING
Umhlanga
Contact Information
Primary
Elizabeth Chong, MSc
Clinicaltrialsinfo@mundipharma-rd.eu
+441223424900
Backup
Terry Nichols
Clinicaltrialsinfo@mundipharma-rd.eu
Time Frame
Start Date: 2023-11-14
Estimated Completion Date: 2025-08
Participants
Target number of participants: 50
Treatments
Experimental: Rezafungin Acetate /Co-trimoxazole
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
Active_comparator: Co-trimoxazole
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
Sponsors
Leads: Mundipharma Research Limited

This content was sourced from clinicaltrials.gov