Efficacy and Safety of Oral Encochleated Amphotericin B for the Treatment of Cryptococcal Infection
Phase 1
Withdrawn
- Conditions
- Cryptococcal Infections
- Interventions
- Drug: Encochleated Amphotericin B
- Registration Number
- NCT03196921
- Lead Sponsor
- Matinas BioPharma Nanotechnologies, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Symptomatic Cryptococcal Meningitis Encochleated Amphotericin B CAMB (Encochleated Amphotericin B) Asymptomatic Cryptococcal Antigenemia Encochleated Amphotericin B CAMB (Encochleated Amphotericin B)
- Primary Outcome Measures
Name Time Method Tolerability of drug over 14 days of dosing 14-days Tolerability of drug as measured by the proportion of doses received versus the number of scheduled doses
Microbiologic clearance of Cryptococcus from the CSF 14-days
- Secondary Outcome Measures
Name Time Method Pharmacokinetics 24-hours PK parameter of the maximum concentration (Cmax)
Incidence of adverse events 14-days stratified by symptomatic and asymptomatic subgroups
Survival from cryptococcal infection 10-weeks stratified by symptomatic and asymptomatic subgroups