Clinical Trials

MainTitle

AmB Dose for Cryptococcal Meningitis

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified October 2019 by Jun Chen, Shanghai Public Health Clinical Center

Sponsor
Shanghai Public Health Clinical Center


Information provided by (Responsible Party)
Jun Chen, Shanghai Public Health Clinical Center

ClinicalTrials.gov Identifier
NCT04140461

First received: October 24, 2019
Last updated: October 25, 2019
Last Verified: October 2019
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
Cryptococcal Meningitis
HIV Infections

Drug : Amphotericin B
Drug : Flucytosine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antifungal Treatment of Cryptococcal Meningitis

Further study details as provided by Jun Chen, Shanghai Public Health Clinical Center:

Primary Outcome Measures

  • Number of subjects died at weeks 48 [ Time Frame: 48 weeks after randomization ]
    Mortality in intent to treat population
Secondary Outcome Measures:
  • Number of subjects with CSF culture positive for Cryptococcus at weeks 2 [ Time Frame: 2 weeks after randomization ]
    Antifungal Activity
  • Number of subjects with disability at weeks 48 [ Time Frame: 48 weeks after randomization ]
    Disability rate in intent to treat population
Other Outcome Measures:
  • Treatment-Emergent Adverse Events [ Time Frame: 12 weeks after randomization ]
    All the adverse events occurred after randomization

Estimated Enrollment: 40
Study Start Date: January 2, 2020
Estimated Study Completion Date: April 30, 2022
Estimated Primary Completion Date: March 30, 2022 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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 Name: 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 Name: Antiretroviral therapy
Drug: Flucytosine

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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT04140461

Contacts

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

Locations

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

Sponsors and Collaborators

Shanghai Public Health Clinical Center
More Information

More Information


Responsible Party: Jun Chen, Assistant of the department, Shanghai Public Health Clinical Center  
ClinicalTrials.gov Identifier: NCT04140461   History of Changes  
Other Study ID Numbers: AMBDOSE  
Study First Received: October 24, 2019  
Last Updated: October 25, 2019  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by Jun Chen, Shanghai Public Health Clinical Center:

HIV infection
Cryptococcal Meningitis
Amphotericin B

Additional relevant MeSH terms:
Meningitis, Cryptococcal
HIV Infections
Meningitis
Amphotericin B
Liposomal amphotericin B
Flucytosine

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.