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Status unknownNCT04140461Updated Oct 29, 2019

AmB Dose for Cryptococcal Meningitis

A Phase 3 interventional study of Amphotericin B and Flucytosine in Cryptococcal Meningitis and HIV Infections, sponsored by Shanghai Public Health Clinical Center. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-29.

Sponsored by Shanghai Public Health Clinical Center · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cryptococcal Meningitis
  • HIV Infections

Keywords

  • HIV infection
  • Cryptococcal Meningitis
  • Amphotericin B
03

In context

Meningitis, Cryptococcal

54 studies on the registry are indexed under Meningitis, Cryptococcal; 6 are open to participants now.

This study's planned enrollment of 40 is below the median of 143 across 35 interventional studies indexed under Meningitis, Cryptococcal.

Browse Meningitis, Cryptococcal studies →

Lead sponsor

Shanghai Public Health Clinical Center is the lead sponsor of 38 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Trial

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

    Drug: Amphotericin B · Drug: Flucytosine

  • Active comparator
    Control

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

    Drug: Amphotericin B · Drug: Flucytosine

Interventions

  • DrugAmphotericin B

    The trial group and the control group received AmB 0.5mg/kg for 4 weeks and 0.7mg/kg for 2 weeks respectively.

    Also known as: Antiretroviral therapy

  • DrugFlucytosine

    The trial group and the control group received 100mg/kg for 4 weeks and for 2 weeks respectively.

06

What researchers measure

Primary outcomes

  1. Number of subjects died at weeks 48

    Mortality in intent to treat population

    Time frame: 48 weeks after randomization

Secondary outcomes

  1. Number of subjects with CSF culture positive for Cryptococcus at weeks 2

    Antifungal Activity

    Time frame: 2 weeks after randomization

  2. Number of subjects with disability at weeks 48

    Disability rate in intent to treat population

    Time frame: 48 weeks after randomization

Other outcomes

  1. Treatment-Emergent Adverse Events

    All the adverse events occurred after randomization

    Time frame: 12 weeks after randomization

07

Study locations

1 site
  • Shanghai Public Health Clinical Center
    Shanghai, Shanghai Municipality 201508, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2020; primary completion for Mar 2022, 26 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 24, 2019
First posted
Oct 25, 2019
StartEst.
Jan 2, 2020
Primary completionEst.
Mar 30, 2022
CompletionEst.
Apr 30, 2022
Last update
Oct 29, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04140461
Lead sponsor
Shanghai Public Health Clinical Center
Responsible party
Jun Chen (Assistant of the department, Shanghai Public Health Clinical Center) — Principal investigator
First posted
Oct 25, 2019
Start date
Jan 2, 2020 (estimated)
Primary completion
Mar 30, 2022 (estimated)
Completion
Apr 30, 2022 (estimated)
Last update
Oct 29, 2019

Study contacts

Jun Chen, M.D
Contact
qtchenjun@163.com
+86-21-37990333 ext. 3222

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Amphotericin B · Flucytosine

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Meningitis, Cryptococcal →

Other studies from this sponsor

Shanghai Public Health Clinical Center

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