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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03196921
Recruitment Status : Withdrawn (Protocol redundancy)
First Posted : June 23, 2017
Last Update Posted : March 8, 2019
Sponsor:
Collaborator:
University of Minnesota
Information provided by (Responsible Party):
Matinas BioPharma Nanotechnologies, Inc.

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.

Condition or disease Intervention/treatment Phase
Cryptococcal Infections Drug: Encochleated Amphotericin B Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: A Prospective Cohort to Evaluate the Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB/MAT2203) for the Treatment of Cryptococcal Infection
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


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:
  • CAMB
  • MAT2203

Experimental: Asymptomatic Cryptococcal Antigenemia
CAMB (Encochleated Amphotericin B)
Drug: Encochleated Amphotericin B
lipid-crystal nanoparticle formulation of amphotericin B; oral
Other Names:
  • CAMB
  • MAT2203




Primary Outcome Measures :
  1. 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

  2. Microbiologic clearance of Cryptococcus from the CSF [ Time Frame: 14-days ]

Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: 14-days ]
    stratified by symptomatic and asymptomatic subgroups

  2. Survival from cryptococcal infection [ Time Frame: 10-weeks ]
    stratified by symptomatic and asymptomatic subgroups

  3. Pharmacokinetics [ Time Frame: 24-hours ]
    PK parameter of Area Under the Curve (AUC)

  4. Pharmacokinetics [ Time Frame: 24-hours ]
    PK parameter of the maximum concentration (Cmax)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03196921


Sponsors and Collaborators
Matinas BioPharma Nanotechnologies, Inc.
University of Minnesota
Investigators
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Principal Investigator: David R Boulware, MD, MPH University of Minnesota
Principal Investigator: Tafese Beyene Tufa Asella Teaching Hospital, Arsi University
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Responsible Party: Matinas BioPharma Nanotechnologies, Inc.
ClinicalTrials.gov Identifier: NCT03196921    
Other Study ID Numbers: MB-70009
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Matinas BioPharma Nanotechnologies, Inc.:
amphotericin B
cryptococcal
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Amphotericin B
Liposomal amphotericin B
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antifungal Agents