Three Induction Treatments on Cryptococcal Meningitis

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital of Zhejiang University
• Collaborator: Wenzhou Central Hospital
• Treatments: Amphotericin B; Amphotericin B, deoxycholate drug combination; Deoxycholic Acid; Liposomal amphotericin B; Voriconazole

Criteria

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.