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

NCT05835479 Phase 2 RECRUITING

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.

Details

Lead sponsor	Mundipharma Research Limited
Phase	Phase 2
Status	RECRUITING
Enrolment	50
Start date	2023-11-14
Completion	2025-08

Conditions

• Pneumocystis Pneumonia

Interventions

• Co-Trimoxazole
• Rezafungin Acetate / Co Trimoxazole

Primary outcomes

• Therapeutic failure on Day 8 — 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.

Countries

South Africa