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AmB Dose for Cryptococcal Meningitis

S

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)

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

Trial contacts and locations

1

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Central trial contact

Jun Chen, M.D

Data sourced from clinicaltrials.gov

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