Back to resultsAmB Dose for Cryptococcal Meningitis
Primary Purpose
Cryptococcal Meningitis, HIV Infections
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Amphotericin B
Flucytosine
Sponsored by
About this trial
This is an interventional treatment trial for Cryptococcal Meningitis focused on measuring HIV infection, Cryptococcal Meningitis, Amphotericin B
Eligibility Criteria
Inclusion Criteria:
- Confirmed HIV infection
- Naive to antiretroviral therapy
- Cryptococcal antigen, smear or culture positive in cerebrospinal fluid
- Agree to participate the study
Exclusion Criteria:
- 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
Sites / Locations
- Shanghai Public Health Clinical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Trial
Control
Arm Description
Amphotericin B 0.5 mg/kg IVGTT QD + Flucytosine 100mg/kg PO QD for 4 weeks
Amphotericin B 0.7 mg/kg IVGTT QD + Flucytosine 100mg/kg PO QD for 2 weeks
Outcomes
Primary Outcome Measures
Number of subjects died at weeks 48
Mortality in intent to treat population
Secondary Outcome Measures
Number of subjects with CSF culture positive for Cryptococcus at weeks 2
Antifungal Activity
Number of subjects with disability at weeks 48
Disability rate in intent to treat population
Full Information
NCT ID
NCT04140461
First Posted
October 24, 2019
Last Updated
October 25, 2019
Sponsor
Shanghai Public Health Clinical Center
1. Study Identification
Unique Protocol Identification Number
NCT04140461
Brief Title
AmB Dose for Cryptococcal Meningitis
Official Title
Antifungal Treatment of Cryptococcal Meningitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2020 (Anticipated)
Primary Completion Date
March 30, 2022 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Public Health Clinical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cryptococcal Meningitis, HIV Infections
Keywords
HIV infection, Cryptococcal Meningitis, Amphotericin B
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Trial
Arm Type
Experimental
Arm Description
Amphotericin B 0.5 mg/kg IVGTT QD + Flucytosine 100mg/kg PO QD for 4 weeks
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Amphotericin B 0.7 mg/kg IVGTT QD + Flucytosine 100mg/kg PO QD for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Amphotericin B
Other Intervention Name(s)
Antiretroviral therapy
Intervention Description
The trial group and the control group received AmB 0.5mg/kg for 4 weeks and 0.7mg/kg for 2 weeks respectively.
Intervention Type
Drug
Intervention Name(s)
Flucytosine
Intervention Description
The trial group and the control group received 100mg/kg for 4 weeks and for 2 weeks respectively.
Primary Outcome Measure Information:
Title
Number of subjects died at weeks 48
Description
Mortality in intent to treat population
Time Frame
48 weeks after randomization
Secondary Outcome Measure Information:
Title
Number of subjects with CSF culture positive for Cryptococcus at weeks 2
Description
Antifungal Activity
Time Frame
2 weeks after randomization
Title
Number of subjects with disability at weeks 48
Description
Disability rate in intent to treat population
Time Frame
48 weeks after randomization
Other Pre-specified Outcome Measures:
Title
Treatment-Emergent Adverse Events
Description
All the adverse events occurred after randomization
Time Frame
12 weeks after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed HIV infection
Naive to antiretroviral therapy
Cryptococcal antigen, smear or culture positive in cerebrospinal fluid
Agree to participate the study
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Chen, M.D
Phone
+86-21-37990333
Ext
3222
Email
qtchenjun@163.com
Facility Information:
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201508
Country
China
12. IPD Sharing Statement
Learn more about this trial
AmB Dose for Cryptococcal Meningitis
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