Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
40 participants
INTERVENTIONAL
2020-01-02
2022-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Trial
Amphotericin B 0.5 mg/kg IVGTT QD + Flucytosine 100mg/kg PO QD for 4 weeks
Amphotericin B
The trial group and the control group received AmB 0.5mg/kg for 4 weeks and 0.7mg/kg for 2 weeks respectively.
Flucytosine
The trial group and the control group received 100mg/kg for 4 weeks and for 2 weeks respectively.
Control
Amphotericin B 0.7 mg/kg IVGTT QD + Flucytosine 100mg/kg PO QD for 2 weeks
Amphotericin B
The trial group and the control group received AmB 0.5mg/kg for 4 weeks and 0.7mg/kg for 2 weeks respectively.
Flucytosine
The trial group and the control group received 100mg/kg for 4 weeks and for 2 weeks respectively.
Interventions
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Amphotericin B
The trial group and the control group received AmB 0.5mg/kg for 4 weeks and 0.7mg/kg for 2 weeks respectively.
Flucytosine
The trial group and the control group received 100mg/kg for 4 weeks and for 2 weeks respectively.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Naive to antiretroviral therapy
* Cryptococcal antigen, smear or culture positive in cerebrospinal fluid
* Agree to participate the study
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Shanghai Public Health Clinical Center
OTHER_GOV
Responsible Party
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Jun Chen
Assistant of the department
Locations
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Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Other Identifiers
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AMBDOSE
Identifier Type: -
Identifier Source: org_study_id
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