Cryptococcal Infections
Conditions
Keywords
amphotericin B, cryptococcal
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.
Interventions
DRUGEncochleated Amphotericin B
lipid-crystal nanoparticle formulation of amphotericin B; oral
Sponsors
University of Minnesota
Matinas BioPharma Nanotechnologies, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients with symptomatic cryptococcal meningitis will be enrolled in treatment arm Patients that are CRAG positive will be enrolled the in prevention arm
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | 14-days | stratified by symptomatic and asymptomatic subgroups |
| Survival from cryptococcal infection | 10-weeks | stratified by symptomatic and asymptomatic subgroups |
| Pharmacokinetics | 24-hours | PK parameter of Area Under the Curve (AUC) |
Outcome results
None listed