Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial (EnACT)

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

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-24

Study Completion Date

2023-02-15

Brief Summary

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This study is designed as two sequential trials. The first is a phase I open label trial to evaluate the safety and tolerability of MAT2203. The maximal tolerated and non-toxic daily dose,will then be moved forward into a multi-day safety trial. The Phase II trial will investigate toxicity and early fungicidal activity (EFA) of MAT2203 with flucytosine.

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Detailed Description

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Cryptococcal meningitis has emerged as one of the most frequent and deadly opportunistic infections in HIV patients. Historically, amphotericin B (AMB) has been considered the "gold standard" in antifungal treatments due to its broad spectrum of activity and lack of emergence of resistance. However, the use of AMB is limited by side effects, including nephrotoxicity, anemia, and infusion-related reactions. MAT2203 or encochleated oral amphotericin B (cAMB) is a lipid nano-crystal formulation designed for targeted oral delivery of the antifungal drug AMB for treatment of fungal and parasitic infections.

Conditions

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Cryptococcal Meningitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Phase I: Persons in Uganda without meningitis or active infections Phase II: HIV-infected persons in Uganda with cryptococcal meningitis

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 1a single ascending dose study

Phase IA will consist of a single ascending dose study in 9 participants to test three doses to determine the max tolerated dose.

Group Type EXPERIMENTAL

MAT2203

Intervention Type DRUG

Encochleated amphotericin B

Phase 1b multiple day dosing

9 subjects will receive the Phase Ia 100% tolerated MAT2203 dose for 7 days.

Group Type EXPERIMENTAL

MAT2203

Intervention Type DRUG

Encochleated amphotericin B

Phase 2 safety and tolerability

Safety, tolerability, and microbiologic efficacy of MAT2203 among HIV-infected patients with cryptococcal meningitis compared with standard IV AMB.

Group Type EXPERIMENTAL

MAT2203

Intervention Type DRUG

Encochleated amphotericin B

Amphotericin B

Intervention Type DRUG

Intravenous amphotericin B

Interventions

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MAT2203

Encochleated amphotericin B

Intervention Type DRUG

Amphotericin B

Intravenous amphotericin B

Intervention Type DRUG

Other Intervention Names

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oral amphotericin B

Eligibility Criteria

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Inclusion Criteria

* Phase 1:

* Age \>18 years
* Calculated creatinine clearance \>70 mL/min/1.73 m2 (measured within 3 months)
* Written informed consent

Phase 2:

* Cryptococcal meningitis diagnosed by CSF cryptococcal antigen (CRAG)
* Ability and willingness to provide informed consent
* Willing to receive protocol-specified lumbar punctures

Exclusion Criteria

* Phase 1:

* Symptomatic Current illness
* Known significant, untreated health problem
* Inability to take enteral medicine
* Pregnant or breast feeding
* Receiving amphotericin B therapy in past 90 days
* Phase 2:

* Presenting Glasgow Coma Scale (GCS) \< 15
* Received 3 or more doses of IV amphotericin therapy within last 30 days
* Inability to take enteral (oral or nasogastric) medicine
* Cannot or unlikely to attend regular clinic visits
* Pregnancy or breastfeeding
* Receiving chemotherapy or corticosteroids
* Suspected Paradoxical immune reconstitution inflammatory syndrome (IRIS)
* Recent initiation of HIV therapy or ART class switch (within 2 weeks)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No