AmB Dose for Cryptococcal Meningitis

HIV Infections Clinical Trial

Official title:

Antifungal Treatment of Cryptococcal Meningitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04140461
• Other study ID #: AMBDOSE
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: January 2, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: October 2019
• Source: Shanghai Public Health Clinical Center
• Contact: Jun Chen, M.D
• Phone: +86-21-37990333
• Email: qtchenjun[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cryptococcal Meningitis
• HIV Infections
• Meningitis
• Meningitis, Cryptococcal

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Public Health Clinical Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Public Health Clinical Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment-Emergent Adverse Events	All the adverse events occurred after randomization	12 weeks after randomization
Primary	Number of subjects died at weeks 48	Mortality in intent to treat population	48 weeks after randomization
Secondary	Number of subjects with CSF culture positive for Cryptococcus at weeks 2	Antifungal Activity	2 weeks after randomization
Secondary	Number of subjects with disability at weeks 48	Disability rate in intent to treat population	48 weeks after randomization