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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Cryptococcal Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Symptomatic Cryptococcal Meningitis

CAMB (Encochleated Amphotericin B)

Group Type EXPERIMENTAL

Encochleated Amphotericin B

Intervention Type DRUG

lipid-crystal nanoparticle formulation of amphotericin B; oral

Asymptomatic Cryptococcal Antigenemia

CAMB (Encochleated Amphotericin B)

Group Type EXPERIMENTAL

Encochleated Amphotericin B

Intervention Type DRUG

lipid-crystal nanoparticle formulation of amphotericin B; oral

Interventions

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Encochleated Amphotericin B

lipid-crystal nanoparticle formulation of amphotericin B; oral

Intervention Type DRUG

Other Intervention Names

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CAMB MAT2203

Eligibility Criteria

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Inclusion Criteria

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