Three Induction Treatments on Cryptococcal Meningitis (TITOC)

January 31, 2021 updated by: First Affiliated Hospital of Zhejiang University

The Effect and Safety of Three Initial Introduction Treatments on HIV-infected Patients With Cryptococcal Meningitis: A Multi-center, Random and Prospective Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hangzhou
      • Zhenjiang, Hangzhou, China, 310020
        • Lijun Xu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
90-day Cryptococcal Meningitis (CM) related mortality
Time Frame: 90 days
analysis of 90-day CM-related mortality of patients in three induction treatments
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early fungicidal rate in Cerebrospinal fluid (CSF)
Time Frame: 2 weeks
Comparison of 2-week CSF early fungicidal activity in three induction treatments
2 weeks
creatinine elevation
Time Frame: 0-90 days
TO observe the numbers of patients whose creatinine > 110 mmol/L during antifungal therapy
0-90 days
Hypokalemia
Time Frame: 0-90 days
To observe the rate of hypokalemia in three groups during antifungal therapy
0-90 days
anemia
Time Frame: 0-90 days
Comparison of the numbers of patients with hemoglobin <120g/L for male or <110g/L for female.
0-90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Zhejiang University

Collaborators

Wenzhou Central Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 25, 2021

Primary Completion (ANTICIPATED)

July 31, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

June 9, 2019

First Submitted That Met QC Criteria

August 27, 2019

First Posted (ACTUAL)

August 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 2, 2021

Last Update Submitted That Met QC Criteria

January 31, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-014-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

12 months after study finished

IPD Sharing Time Frame

12 months

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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