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TITOC: Three Induction Treatments on Cryptococcal Meningitis

Sponsor
First Affiliated Hospital of Zhejiang University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04072640
Collaborator
Wenzhou Central Hospital (Other)
120
Enrollment
1
Location
3
Arms
22.2
Anticipated Duration (Months)
5.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Voriconazole 200mg
  • Drug: amphotericin B deoxycholate (0.4-0.5mg/kg/d)
  • Drug: Amphotericin B-deoxycholate (0.7-1.0mg/kg/d)
 Early Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect and Safety of Three Initial Introduction Treatments on HIV-infected Patients With Cryptococcal Meningitis: A Multi-center, Random and Prospective Study
Actual Study Start Date :
Jan 25, 2021
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: voriconazole treatment

induction treatment with Voriconazole 200mg bid (IV) + 5FC (100mg/kg/d) for 14 days, consolidation treatment wiht fluconazole 400mg/d for two months, then maintenance treatment with fluconazole 200mg/d

Drug: Voriconazole 200mg
Induction treatment with voriconazole( 400mg/d)+5FC (100mg/kg/d) for 14 days;
Other Names:
  • Voriconazole for Cryptococcus

    		•
    Active Comparator: amphotericin treatment (0.7-1.0mg/kg/d)

    Induction treatment with amphotericin B 0.7-1.0mg/kg/d + 5FC (100mg/kg/d) for 14 days,consolidation treatment wiht fluconazole 400mg/d for two months, then maintenance treatment with fluconazole 200mg/d

    Drug: Amphotericin 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
    Other Names:
  • standard Amphotericin B-deoxycholate for Cryptococcus

    		•
    Experimental: amphotericin B treatment (0.4-0.5mg/kg/d)

    Induction treatment with amphotericin B 0.4-0.5mg/kg/d + 5FC (100mg/kg/d) for 28 days, consolidation treatment with fluconazole 400mg/d for two months, then maintenance treatment with fluconazole 200mg/d

    Drug: amphotericin 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
    Other Names:
  • low dose and long course of Amphotericin B-deoxycholate

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 90-day Cryptococcal Meningitis (CM) related mortality [90 days]

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

    Secondary Outcome Measures

    1. Early fungicidal rate in Cerebrospinal fluid (CSF) [2 weeks]

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

    2. creatinine elevation [0-90 days]

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

    3. Hypokalemia [0-90 days]

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

    4. anemia [0-90 days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    1. patients who are unwilling to anticipate.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lijun Xu Zhenjiang Hangzhou China 310020

    Sponsors and Collaborators

    • First Affiliated Hospital of Zhejiang University
    • Wenzhou Central Hospital

    Investigators

    • Principal Investigator: Lijun Xu, PH.D, Zhejiang University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    First Affiliated Hospital of Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT04072640
    Other Study ID Numbers:
    • 2018-014-1
    First Posted:
    Aug 28, 2019
    Last Update Posted:
    Feb 2, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by First Affiliated Hospital of Zhejiang University
    Voriconazole;amphotericin ;cryptococcal meningitis
    Additional relevant MeSH terms:
    Meningitis, Cryptococcal
    Meningitis
    Voriconazole
    Amphotericin B
    Liposomal amphotericin B
    Amphotericin B, deoxycholate drug combination
    Deoxycholic Acid

    Study Results

    No Results Posted as of Feb 2, 2021