Cryptococcal Meningitis, HIV Infections
Conditions
Keywords
HIV infection, Cryptococcal Meningitis, Amphotericin B
Brief 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.
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.
DRUGFlucytosine
The trial group and the control group received 100mg/kg for 4 weeks and for 2 weeks respectively.
Sponsors
Shanghai Public Health Clinical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects died at weeks 48 | 48 weeks after randomization | Mortality in intent to treat population |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with CSF culture positive for Cryptococcus at weeks 2 | 2 weeks after randomization | Antifungal Activity |
| Number of subjects with disability at weeks 48 | 48 weeks after randomization | Disability rate in intent to treat population |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment-Emergent Adverse Events | 12 weeks after randomization | All the adverse events occurred after randomization |
Countries
China
Contacts
Primary ContactJun Chen, M.D
Outcome results
None listed