RecruitingPhase 2NCT05835479

Rezafungin for Treatment of Pneumocystis Pneumonia in HIV Adults

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


Sponsor

Mundipharma Research Limited

Enrollment

50 participants

Start Date

Nov 14, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether rezafungin — an antifungal drug given by injection once a week — can effectively treat Pneumocystis pneumonia (PCP), a serious lung infection that commonly affects people with HIV whose immune systems are weakened. The study compares rezafungin to standard treatment to see if it is equally effective and safe. **You may be eligible if...** - You are 18 or older and HIV-positive - You have been diagnosed with Pneumocystis pneumonia (PCP) or are strongly suspected to have it - You are willing to use contraception during and after the study if applicable **You may NOT be eligible if...** - You are under 18 - You have a known allergy to any echinocandin antifungal drug (a family that includes rezafungin) or to co-trimoxazole (a standard PCP treatment) - You are pregnant or at risk of pregnancy without agreeing to contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCo-Trimoxazole

Oral co-trimoxazole or Intravenous (IV) co-trimoxazole for infusion. Anti fungal medication

DRUGRezafungin Acetate / Co Trimoxazole

Rezafungin for infusion. Intravenous anti fungal therapy Oral co-trimoxazole or Intravenous (IV) co-trimoxazole for infusion. Anti fungal medication


Locations(6)

University of Cape Town

Cape Town, South Africa

Charlotte Maxeke Johannesburg Academic Hospital

Johannesburg, South Africa

Helen Joseph Hospital

Johannesburg, South Africa

Global Clinical Trials - Pretoria

Pretoria, South Africa

Steve Biko Academic Hospital

Pretoria, South Africa

Netcare Umhlanga Medical Centre

Umhlanga, South Africa

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05835479


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