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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04140461
Other study ID # AMBDOSE
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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