AmB Dose for Cryptococcal Meningitis
Antifungal Treatment of Cryptococcal Meningitis
1 other identifier
interventional
40
1 country
1
Brief Summary
Cryptococcal meningitis (CM) is one of the leading opportunistic infections and one of the most common causes of death in AIDS patients. Amphotericin B (AmB) is the corner stone in CM treatment. The effect of AmB was dose-dependent. Recent retrospective study indicated that longer duration rather than higher dose of AmB is necessary to reduce the mortality of CM. We aimed to explore the efficacy and safety of small dose but longer duration of AmB for the treatment of HIV-associated CM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2019
CompletedFirst Posted
Study publicly available on registry
October 25, 2019
CompletedStudy Start
First participant enrolled
January 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedOctober 29, 2019
October 1, 2019
2.2 years
October 24, 2019
October 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of subjects died at weeks 48
Mortality in intent to treat population
48 weeks after randomization
Secondary Outcomes (2)
Number of subjects with CSF culture positive for Cryptococcus at weeks 2
2 weeks after randomization
Number of subjects with disability at weeks 48
48 weeks after randomization
Other Outcomes (1)
Treatment-Emergent Adverse Events
12 weeks after randomization
Study Arms (2)
Trial
EXPERIMENTALAmphotericin B 0.5 mg/kg IVGTT QD + Flucytosine 100mg/kg PO QD for 4 weeks
Control
ACTIVE COMPARATORAmphotericin B 0.7 mg/kg IVGTT QD + Flucytosine 100mg/kg PO QD for 2 weeks
Interventions
The trial group and the control group received AmB 0.5mg/kg for 4 weeks and 0.7mg/kg for 2 weeks respectively.
The trial group and the control group received 100mg/kg for 4 weeks and for 2 weeks respectively.
Eligibility Criteria
You may qualify if:
- Confirmed HIV infection
- Naive to antiretroviral therapy
- Cryptococcal antigen, smear or culture positive in cerebrospinal fluid
- Agree to participate the study
You may not qualify if:
- Having receiving antifungal treatment for ≥3 days
- ALT or AST \> 5\* upper limit of detection (ULD), or neutrophil\< 0.5\*10E9 cells/L, or hemoglobin \< 90g/L or platelet \<50\*10E9/L or serum creatinine \> ULD
- Pregnancy or breastfeeding
- Concomitant medications that are contraindicated with any research drug
- Any other contraindications for using amphotericin B or 5FC
- Inability to follow-up as accessed by the investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant of the department
Study Record Dates
First Submitted
October 24, 2019
First Posted
October 25, 2019
Study Start
January 2, 2020
Primary Completion
March 30, 2022
Study Completion
April 30, 2022
Last Updated
October 29, 2019
Record last verified: 2019-10