AmB Dose for Cryptococcal Meningitis

Phase 3

• Conditions: Cryptococcal Meningitis; HIV Infections
• Interventions: Drug: Amphotericin B; Drug: Flucytosine

• Registration Number: NCT04140461
• Lead Sponsor: Shanghai Public Health Clinical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-24
• Study First Submitted QC: 2019-10-24
• Study First Posted: 2019-10-25
• Last Update Submitted: 2019-10-25
• Last Update Posted: 2019-10-29
• Study Start: 2020-01-02
• Primary Completion: 2022-03-30
• Study Completion: 2022-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Amphotericin B	Amphotericin B 0.7 mg/kg IVGTT QD + Flucytosine 100mg/kg PO QD for 2 weeks
Trial	Flucytosine	Amphotericin B 0.5 mg/kg IVGTT QD + Flucytosine 100mg/kg PO QD for 4 weeks
Trial	Amphotericin B	Amphotericin B 0.5 mg/kg IVGTT QD + Flucytosine 100mg/kg PO QD for 4 weeks
Control	Flucytosine	Amphotericin B 0.7 mg/kg IVGTT QD + Flucytosine 100mg/kg PO QD for 2 weeks

Primary Outcome Measures

Name	Time	Method
Number of subjects died at weeks 48	48 weeks after randomization	Mortality in intent to treat population

Secondary Outcome Measures

Name	Time	Method
Number of subjects with disability at weeks 48	48 weeks after randomization	Disability rate in intent to treat population
Number of subjects with CSF culture positive for Cryptococcus at weeks 2	2 weeks after randomization	Antifungal Activity

Trial Locations

Locations (1)

Shanghai Public Health Clinical Center; 🇨🇳 Shanghai, Shanghai, China