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

Phase 2WithdrawnNCT03196921

Matinas BioPharma Nanotechnologies, Inc.

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Cryptococcal Infections

Interventions

Encochleated Amphotericin BDRUG

lipid-crystal nanoparticle formulation of amphotericin B; oral

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 14-days

Microbiologic clearance of Cryptococcus from the CSF

Time frame: 14-days

Secondary Outcomes

Incidence of adverse events

stratified by symptomatic and asymptomatic subgroups

Time frame: 14-days

Survival from cryptococcal infection

stratified by symptomatic and asymptomatic subgroups

Time frame: 10-weeks

Pharmacokinetics

PK parameter of Area Under the Curve (AUC)

Time frame: 24-hours

Pharmacokinetics

PK parameter of the maximum concentration (Cmax)

Time frame: 24-hours

Data from ClinicalTrials.gov

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