Efficacy and Safety of Oral Encochleated Amphotericin B for the Treatment of Cryptococcal Infection

• Status: Withdrawn
• Trial end date: 2020-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This will be an open label phase I/II prospective cohort study to determine the efficacy and safety of CAMB for the treatment and prevention of cryptococcal infection.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Matinas BioPharma Nanotechnologies, Inc.
• Collaborators: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Treatments: Amphotericin B; Liposomal amphotericin B

Criteria

Inclusion Criteria:

• HIV infection, informed consent, cryptococcal infection present, diagnosed by either:

CSF cryptococcal culture, CSF cryptococcal antigen (CRAG), plasma/serum CRAG

Exclusion Criteria:

• Presence of jaundice or known liver cirrhosis, >72 hours antifungal therapy, pregnancy or breastfeeding, unlikely to attend regular clinic visits