UnknownPhase 3

AmB Dose for Cryptococcal Meningitis

China40 participantsStarted 2020-01-02

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Number of subjects died at weeks 48

Timeframe: 48 weeks after randomization

Trial details

NCT IDNCT04140461

SponsorShanghai Public Health Clinical Center

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2022-03-30

Contact for this trial

Jun Chen, M.D

+86-21-37990333 qtchenjun@163.com

View on ClinicalTrials.gov More Cryptococcal Meningitis trials