Three Induction Treatments on Cryptococcal Meningitis

Early Phase 1UnknownNCT04072640

First Affiliated Hospital of Zhejiang University120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Cryptococcal Meningitis HIV/AIDS

Interventions

Voriconazole 200mgDRUG

Induction treatment with voriconazole( 400mg/d)+5FC (100mg/kg/d) for 14 days;

amphotericin B deoxycholate (0.4-0.5mg/kg/d)DRUG

Induction treatment with 0.4-0.5mg/kg/d of Amphotericin B-deoxycholate +5FC(100mg/kg/d) for 28 days

Amphotericin B-deoxycholate (0.7-1.0mg/kg/d)DRUG

Induction treatment with 0.7-1.0mg/kg/d of Amphotericin B-deoxycholate +5FC(100mg/kg/d) for 14 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Lijun Xu

Zhenjiang, Hangzhou, China

Outcomes

Primary Outcomes

90-day Cryptococcal Meningitis (CM) related mortality

analysis of 90-day CM-related mortality of patients in three induction treatments

Time frame: 90 days

Secondary Outcomes

Early fungicidal rate in Cerebrospinal fluid (CSF)

Comparison of 2-week CSF early fungicidal activity in three induction treatments

Time frame: 2 weeks

creatinine elevation

TO observe the numbers of patients whose creatinine \> 110 mmol/L during antifungal therapy

Time frame: 0-90 days

Hypokalemia

To observe the rate of hypokalemia in three groups during antifungal therapy

Time frame: 0-90 days

anemia

Comparison of the numbers of patients with hemoglobin \<120g/L for male or \<110g/L for female.

Time frame: 0-90 days

Data from ClinicalTrials.gov

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