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

Matinas BioPharma

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Cryptococcal Infections

Treatments: Drug: Encochleated Amphotericin B

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03196921

MB-70009

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Symptomatic Cryptococcal Meningitis

Experimental group

Description:

CAMB (Encochleated Amphotericin B)

Treatment:

Drug: Encochleated Amphotericin B

Asymptomatic Cryptococcal Antigenemia

Experimental group

Description:

CAMB (Encochleated Amphotericin B)

Treatment:

Drug: Encochleated Amphotericin B