- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03196921
Efficacy and Safety of Oral Encochleated Amphotericin B for the Treatment of Cryptococcal Infection (ORACLE)
March 6, 2019 updated by: Matinas BioPharma Nanotechnologies, Inc.
A Prospective Cohort to Evaluate the Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB/MAT2203) for the Treatment of Cryptococcal Infection
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Symptomatic Cryptococcal Meningitis
CAMB (Encochleated Amphotericin B)
|
lipid-crystal nanoparticle formulation of amphotericin B; oral
Other Names:
|
EXPERIMENTAL: Asymptomatic Cryptococcal Antigenemia
CAMB (Encochleated Amphotericin B)
|
lipid-crystal nanoparticle formulation of amphotericin B; oral
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
14-days
|
Microbiologic clearance of Cryptococcus from the CSF
Time Frame: 14-days
|
14-days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events
Time Frame: 14-days
|
stratified by symptomatic and asymptomatic subgroups
|
14-days
|
Survival from cryptococcal infection
Time Frame: 10-weeks
|
stratified by symptomatic and asymptomatic subgroups
|
10-weeks
|
Pharmacokinetics
Time Frame: 24-hours
|
PK parameter of Area Under the Curve (AUC)
|
24-hours
|
Pharmacokinetics
Time Frame: 24-hours
|
PK parameter of the maximum concentration (Cmax)
|
24-hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Tafese Beyene Tufa, Asella Teaching Hospital, Arsi University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
October 1, 2018
Primary Completion (ANTICIPATED)
October 1, 2019
Study Completion (ANTICIPATED)
March 1, 2020
Study Registration Dates
First Submitted
June 19, 2017
First Submitted That Met QC Criteria
June 20, 2017
First Posted (ACTUAL)
June 23, 2017
Study Record Updates
Last Update Posted (ACTUAL)
March 8, 2019
Last Update Submitted That Met QC Criteria
March 6, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MB-70009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Matinas BioPharma Nanotechnologies, Inc.CompletedVulvovaginitis | Candidiasis, Vulvovaginal | Yeast Infection | Yeast Infection VaginalUnited States
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Astellas Pharma Global Development, Inc.TerminatedCandidiasisPhilippines, United States, Canada, Israel, Romania, Greece, Turkey, Brazil, Bulgaria, Colombia, Hungary, Ukraine
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Southeast University, ChinaCompleted
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LiposomeCompletedHIV Infections | Meningitis, CryptococcalUnited States