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

Cryptococcal Infections Clinical Trial

— ORACLE  

Official title:

A Prospective Cohort to Evaluate the Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB/MAT2203) for the Treatment of Cryptococcal Infection

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03196921
• Other study ID #: MB-70009
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: October 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: March 2019
• Source: Matinas BioPharma Nanotechnologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 1, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Cryptococcal Infections
• Infection

Intervention

Drug:
• Encochleated Amphotericin B
lipid-crystal nanoparticle formulation of amphotericin B; oral

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Matinas BioPharma Nanotechnologies, Inc.	University of Minnesota - Clinical and Translational Science Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability of drug over 14 days of dosing	Tolerability of drug as measured by the proportion of doses received versus the number of scheduled doses	14-days
Primary	Microbiologic clearance of Cryptococcus from the CSF		14-days
Secondary	Incidence of adverse events	stratified by symptomatic and asymptomatic subgroups	14-days
Secondary	Survival from cryptococcal infection	stratified by symptomatic and asymptomatic subgroups	10-weeks
Secondary	Pharmacokinetics	PK parameter of Area Under the Curve (AUC)	24-hours
Secondary	Pharmacokinetics	PK parameter of the maximum concentration (Cmax)	24-hours