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Protocol redundancy
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| Name | Class |
|---|---|
| University of Minnesota | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symptomatic Cryptococcal Meningitis | Experimental | CAMB (Encochleated Amphotericin B) |
|
| Asymptomatic Cryptococcal Antigenemia | Experimental | CAMB (Encochleated Amphotericin B) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Encochleated Amphotericin B | Drug | lipid-crystal nanoparticle formulation of amphotericin B; oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of drug over 14 days of dosing | 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 | 14-days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | stratified by symptomatic and asymptomatic subgroups | 14-days |
| Survival from cryptococcal infection | stratified by symptomatic and asymptomatic subgroups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David R Boulware, MD, MPH | University of Minnesota | Principal Investigator |
| Tafese Beyene Tufa | Asella Teaching Hospital, Arsi University | Principal Investigator |
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Patients with symptomatic cryptococcal meningitis will be enrolled in treatment arm Patients that are CRAG positive will be enrolled the in prevention arm
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|
| 10-weeks |
| Pharmacokinetics | PK parameter of Area Under the Curve (AUC) | 24-hours |
| Pharmacokinetics | PK parameter of the maximum concentration (Cmax) | 24-hours |