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

NCT03196921 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: MB-70009
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cryptococcal Infections

Keywords

amphotericin B; cryptococcal

Outcome Measures

Primary Outcomes (2)

• 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

  14-days

• Microbiologic clearance of Cryptococcus from the CSF

  14-days

Secondary Outcomes (4)

• Incidence of adverse events

  14-days

• Survival from cryptococcal infection

  10-weeks

• Pharmacokinetics

  24-hours

• Pharmacokinetics

  24-hours

Study Arms (2)

Symptomatic Cryptococcal Meningitis

EXPERIMENTAL

CAMB (Encochleated Amphotericin B)

Drug: Encochleated Amphotericin B

Asymptomatic Cryptococcal Antigenemia

EXPERIMENTAL

CAMB (Encochleated Amphotericin B)

Drug: Encochleated Amphotericin B

Interventions

Encochleated Amphotericin B DRUG

lipid-crystal nanoparticle formulation of amphotericin B; oral

Also known as: CAMB, MAT2203

Asymptomatic Cryptococcal Antigenemia; Symptomatic Cryptococcal Meningitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV infection, informed consent, cryptococcal infection present, diagnosed by either: CSF cryptococcal culture, CSF cryptococcal antigen (CRAG), plasma/serum CRAG

You may not qualify if:

• Presence of jaundice or known liver cirrhosis, \>72 hours antifungal therapy, pregnancy or breastfeeding, unlikely to attend regular clinic visits

Sponsors & Collaborators

• Matinas BioPharma Nanotechnologies, Inc.: lead
• University of Minnesota: collaborator

Study Officials

• David R Boulware, MD, MPH

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Tafese Beyene Tufa

  Asella Teaching Hospital, Arsi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients with symptomatic cryptococcal meningitis will be enrolled in treatment arm Patients that are CRAG positive will be enrolled the in prevention arm

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 23, 2017
• Study Start: October 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: March 1, 2020
• Last Updated: March 8, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share