Back to resultsEfficacy 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Withdrawn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
About this trial
This is an interventional treatment trial for Cryptococcal Infections focused on measuring amphotericin B, cryptococcal
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
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
NCT ID
NCT03196921
First Posted
June 19, 2017
Last Updated
March 6, 2019
Sponsor
Matinas BioPharma Nanotechnologies, Inc.
Collaborators
University of Minnesota
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Withdrawn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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