NCT03196921WithdrawnPhase 1
A Prospective Cohort to Evaluate the Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB/MAT2203) for the Treatment of Cryptococcal Infection
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Primary Endpoint
- Tolerability of drug over 14 days of dosing
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Symptomatic Cryptococcal Meningitis
Experimental
CAMB (Encochleated Amphotericin B)
Intervention: Encochleated Amphotericin B (Drug)
Asymptomatic Cryptococcal Antigenemia
Experimental
CAMB (Encochleated Amphotericin B)
Intervention: Encochleated Amphotericin B (Drug)
Outcomes
Primary Outcomes
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
Microbiologic clearance of Cryptococcus from the CSF
Time Frame: 14-days
Secondary Outcomes
- Pharmacokinetics(24-hours)
- Incidence of adverse events(14-days)
- Survival from cryptococcal infection(10-weeks)
Investigators
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