Cryptococcal Meningitis, HIV/AIDS
Conditions
Keywords
Voriconazole;amphotericin ;cryptococcal meningitis
Brief summary
Three induction treatment strategies \[ voriconazole +5FC vs. amphotericin deoxycholate (0.4-0.5 mg/kg/d)+5FC vs. amphotericin deoxycholate (0.7-1.0 mg/kg/d)+5FC \] for HIV-infected patients with cryptococcal meningitis were compared.
Detailed description
HIV-associated cryptococcal meningitis were randomly allocated into three induction treatment as follow: 1) 14 days of voriconazole 200mg bid +5FC, 2) 28 days of amphotericin deoxycholate (0.4-0.5 mg/kg/d) +5FC ; 3）14 days of deoxycholate (0.7-1 mg/kg/d) +5FC). After induction treatment were finished, all groups switched into fluconazole(400mg/d) for two-month consolidation treatment. 14-day early fungicidal rate, 90-day mortality, side effects , and tolerances were compared between three groups.
Interventions
Induction treatment with voriconazole( 400mg/d)+5FC (100mg/kg/d) for 14 days;
DRUGamphotericin B deoxycholate (0.4-0.5mg/kg/d)
Induction treatment with 0.4-0.5mg/kg/d of Amphotericin B-deoxycholate +5FC(100mg/kg/d) for 28 days
DRUGAmphotericin B-deoxycholate (0.7-1.0mg/kg/d)
Induction treatment with 0.7-1.0mg/kg/d of Amphotericin B-deoxycholate +5FC(100mg/kg/d) for 14 days
Sponsors
First Affiliated Hospital of Zhejiang University
Wenzhou Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosis of HIV infection; 2. newly diagnosed Cryptococcal Meningitis by positive India ink staining or culture result, or both in cerebrospinal fluid (CSF); 3. Anti-viral treatment naïve patients 4. anti-fungal treatment naïve patients
Exclusion criteria
1. hepatitis virus co-infection; 2. liver cirrhosis; 3. congestive heart failure; 4. chronic renal disorders; 5. chronic obstructive pulmonary disease (COPD); 6. Tuberculosis co-infection; 7. malignances 8. severe mental and neurological diseases 9. Women during pregnancy and lactation 10. intraveneous drug user (IDU) 11. patients with follow abnormal test results:hemoglobin \< 6 g/dl, white blood cell count \< 2000 / μl, neutrophil count \< 1000 / μl, platelet count \< 75000 / μl, blood amylase \> 3 times normal level Upper limit, serum creatinine \> 1.5 times normal upper limit, aspartate aminotransferase / alanine aminotransferase / alkaline phosphatase \> 3 times normal upper limit, total bilirubin \> 2 times normal upper limit 12. patients who are unwilling to anticipate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 90-day Cryptococcal Meningitis (CM) related mortality | 90 days | analysis of 90-day CM-related mortality of patients in three induction treatments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early fungicidal rate in Cerebrospinal fluid (CSF) | 2 weeks | Comparison of 2-week CSF early fungicidal activity in three induction treatments |
| creatinine elevation | 0-90 days | TO observe the numbers of patients whose creatinine \> 110 mmol/L during antifungal therapy |
| Hypokalemia | 0-90 days | To observe the rate of hypokalemia in three groups during antifungal therapy |
| anemia | 0-90 days | Comparison of the numbers of patients with hemoglobin \<120g/L for male or \<110g/L for female. |
Countries
China
Outcome results
None listed