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

Primary Purpose

Cryptococcal Infections

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Encochleated Amphotericin B
Sponsored by
Matinas BioPharma Nanotechnologies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cryptococcal Infections focused on measuring amphotericin B, cryptococcal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Symptomatic Cryptococcal Meningitis

    Asymptomatic Cryptococcal Antigenemia

    Arm Description

    CAMB (Encochleated Amphotericin B)

    CAMB (Encochleated Amphotericin B)

    Outcomes

    Primary Outcome Measures

    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
    Microbiologic clearance of Cryptococcus from the CSF

    Secondary Outcome Measures

    Incidence of adverse events
    stratified by symptomatic and asymptomatic subgroups
    Survival from cryptococcal infection
    stratified by symptomatic and asymptomatic subgroups
    Pharmacokinetics
    PK parameter of Area Under the Curve (AUC)
    Pharmacokinetics
    PK parameter of the maximum concentration (Cmax)

    Full Information

    First Posted
    June 19, 2017
    Last Updated
    March 6, 2019
    Sponsor
    Matinas BioPharma Nanotechnologies, Inc.
    Collaborators
    University of Minnesota
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03196921
    Brief Title
    Efficacy and Safety of Oral Encochleated Amphotericin B for the Treatment of Cryptococcal Infection
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Protocol redundancy
    Study Start Date
    October 1, 2018 (Anticipated)
    Primary Completion Date
    October 1, 2019 (Anticipated)
    Study Completion Date
    March 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Matinas BioPharma Nanotechnologies, Inc.
    Collaborators
    University of Minnesota

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cryptococcal Infections
    Keywords
    amphotericin B, cryptococcal

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Sequential Assignment
    Model Description
    Patients with symptomatic cryptococcal meningitis will be enrolled in treatment arm Patients that are CRAG positive will be enrolled the in prevention arm
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Symptomatic Cryptococcal Meningitis
    Arm Type
    Experimental
    Arm Description
    CAMB (Encochleated Amphotericin B)
    Arm Title
    Asymptomatic Cryptococcal Antigenemia
    Arm Type
    Experimental
    Arm Description
    CAMB (Encochleated Amphotericin B)
    Intervention Type
    Drug
    Intervention Name(s)
    Encochleated Amphotericin B
    Other Intervention Name(s)
    CAMB, MAT2203
    Intervention Description
    lipid-crystal nanoparticle formulation of amphotericin B; oral
    Primary Outcome Measure Information:
    Title
    Tolerability of drug over 14 days of dosing
    Description
    Tolerability of drug as measured by the proportion of doses received versus the number of scheduled doses
    Time Frame
    14-days
    Title
    Microbiologic clearance of Cryptococcus from the CSF
    Time Frame
    14-days
    Secondary Outcome Measure Information:
    Title
    Incidence of adverse events
    Description
    stratified by symptomatic and asymptomatic subgroups
    Time Frame
    14-days
    Title
    Survival from cryptococcal infection
    Description
    stratified by symptomatic and asymptomatic subgroups
    Time Frame
    10-weeks
    Title
    Pharmacokinetics
    Description
    PK parameter of Area Under the Curve (AUC)
    Time Frame
    24-hours
    Title
    Pharmacokinetics
    Description
    PK parameter of the maximum concentration (Cmax)
    Time Frame
    24-hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David R Boulware, MD, MPH
    Organizational Affiliation
    University of Minnesota
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Tafese Beyene Tufa
    Organizational Affiliation
    Asella Teaching Hospital, Arsi University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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