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

March 6, 2019 updated by: Matinas BioPharma Nanotechnologies, Inc.

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Symptomatic Cryptococcal Meningitis
CAMB (Encochleated Amphotericin B)
Drug: Encochleated Amphotericin B
lipid-crystal nanoparticle formulation of amphotericin B; oral
Other Names:
  • MAT2203
  • CAMB
EXPERIMENTAL: Asymptomatic Cryptococcal Antigenemia
CAMB (Encochleated Amphotericin B)
Drug: Encochleated Amphotericin B
lipid-crystal nanoparticle formulation of amphotericin B; oral
Other Names:
  • MAT2203
  • CAMB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerability of drug over 14 days of dosing
Time Frame: 14-days
Tolerability of drug as measured by the proportion of doses received versus the number of scheduled doses
14-days
Microbiologic clearance of Cryptococcus from the CSF
Time Frame: 14-days
14-days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: 14-days
stratified by symptomatic and asymptomatic subgroups
14-days
Survival from cryptococcal infection
Time Frame: 10-weeks
stratified by symptomatic and asymptomatic subgroups
10-weeks
Pharmacokinetics
Time Frame: 24-hours
PK parameter of Area Under the Curve (AUC)
24-hours
Pharmacokinetics
Time Frame: 24-hours
PK parameter of the maximum concentration (Cmax)
24-hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Matinas BioPharma Nanotechnologies, Inc.

Collaborators

University of Minnesota

Investigators

  • Principal Investigator: Tafese Beyene Tufa, Asella Teaching Hospital, Arsi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2018

Primary Completion (ANTICIPATED)

October 1, 2019

Study Completion (ANTICIPATED)

March 1, 2020

Study Registration Dates

First Submitted

June 19, 2017

First Submitted That Met QC Criteria

June 20, 2017

First Posted (ACTUAL)

June 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 8, 2019

Last Update Submitted That Met QC Criteria

March 6, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MB-70009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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