AmB Dose for Cryptococcal Meningitis

Shanghai Public Health Clinical Center

Status and phase: Unknown; Phase 3

Conditions: HIV Infections; Cryptococcal Meningitis

Treatments: Drug: Amphotericin B; Drug: Flucytosine

Study type: Interventional

Funder types: Other

Identifiers

NCT04140461

AMBDOSE

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Trial

Experimental group

Description:

Amphotericin B 0.5 mg/kg IVGTT QD + Flucytosine 100mg/kg PO QD for 4 weeks

Treatment:

Drug: Flucytosine

Drug: Amphotericin B

Control

Active Comparator group

Description:

Amphotericin B 0.7 mg/kg IVGTT QD + Flucytosine 100mg/kg PO QD for 2 weeks

Treatment:

Drug: Flucytosine

Drug: Amphotericin B