Status:
UNKNOWN
Three Induction Treatments on Cryptococcal Meningitis
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Collaborating Sponsors:
Wenzhou Central Hospital
Conditions:
Cryptococcal Meningitis
HIV/AIDS
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
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 cryp...
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/...
Eligibility Criteria
Inclusion
- Clinical diagnosis of HIV infection;
- newly diagnosed Cryptococcal Meningitis by positive India ink staining or culture result, or both in cerebrospinal fluid (CSF);
- Anti-viral treatment naïve patients
- anti-fungal treatment naïve patients
Exclusion
- hepatitis virus co-infection;
- liver cirrhosis;
- congestive heart failure;
- chronic renal disorders;
- chronic obstructive pulmonary disease (COPD);
- Tuberculosis co-infection;
- malignances
- severe mental and neurological diseases
- Women during pregnancy and lactation
- intraveneous drug user (IDU)
- 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
- patients who are unwilling to anticipate.
Key Trial Info
Start Date :
January 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04072640
Start Date
January 25 2021
End Date
December 1 2022
Last Update
February 2 2021
Active Locations (1)
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1
Lijun Xu
Zhenjiang, Hangzhou, China, 310020