AmB Dose for Cryptococcal Meningitis

October 25, 2019 updated by: Jun Chen, Shanghai Public Health Clinical Center

Antifungal Treatment of Cryptococcal Meningitis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201508
        • Shanghai Public Health Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Trial
Amphotericin B 0.5 mg/kg IVGTT QD + Flucytosine 100mg/kg PO QD for 4 weeks
Drug: Amphotericin B
The trial group and the control group received AmB 0.5mg/kg for 4 weeks and 0.7mg/kg for 2 weeks respectively.
Other Names:
  • Antiretroviral therapy
Drug: Flucytosine
The trial group and the control group received 100mg/kg for 4 weeks and for 2 weeks respectively.
ACTIVE_COMPARATOR: Control
Amphotericin B 0.7 mg/kg IVGTT QD + Flucytosine 100mg/kg PO QD for 2 weeks
Drug: Amphotericin B
The trial group and the control group received AmB 0.5mg/kg for 4 weeks and 0.7mg/kg for 2 weeks respectively.
Other Names:
  • Antiretroviral therapy
Drug: Flucytosine
The trial group and the control group received 100mg/kg for 4 weeks and for 2 weeks respectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects died at weeks 48
Time Frame: 48 weeks after randomization
Mortality in intent to treat population
48 weeks after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects with CSF culture positive for Cryptococcus at weeks 2
Time Frame: 2 weeks after randomization
Antifungal Activity
2 weeks after randomization
Number of subjects with disability at weeks 48
Time Frame: 48 weeks after randomization
Disability rate in intent to treat population
48 weeks after randomization

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-Emergent Adverse Events
Time Frame: 12 weeks after randomization
All the adverse events occurred after randomization
12 weeks after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Public Health Clinical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 2, 2020

Primary Completion (ANTICIPATED)

March 30, 2022

Study Completion (ANTICIPATED)

April 30, 2022

Study Registration Dates

First Submitted

October 24, 2019

First Submitted That Met QC Criteria

October 24, 2019

First Posted (ACTUAL)

October 25, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 29, 2019

Last Update Submitted That Met QC Criteria

October 25, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMBDOSE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Amphotericin B

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe