Three Induction Treatments on Cryptococcal Meningitis

NCT04072640 | Unknown Early Phase 1 DMC

• 1 other identifier: 2018-014-1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cryptococcal Meningitis; HIV/AIDS

Keywords

Voriconazole;amphotericin ;cryptococcal meningitis

Outcome Measures

Primary Outcomes (1)

• 90-day Cryptococcal Meningitis (CM) related mortality

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

  90 days

Secondary Outcomes (4)

• Early fungicidal rate in Cerebrospinal fluid (CSF)

  2 weeks

• creatinine elevation

  0-90 days

• Hypokalemia

  0-90 days

• anemia

  0-90 days

Study Arms (3)

voriconazole treatment

EXPERIMENTAL

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

amphotericin treatment (0.7-1.0mg/kg/d)

ACTIVE COMPARATOR

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)

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

EXPERIMENTAL

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)

Interventions

Voriconazole 200mg DRUG

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

Also known as: Voriconazole for Cryptococcus

voriconazole treatment

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

Also known as: low dose and long course of Amphotericin B-deoxycholate

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

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

Also known as: standard Amphotericin B-deoxycholate for Cryptococcus

amphotericin treatment (0.7-1.0mg/kg/d)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• Wenzhou Central Hospital: collaborator

Study Sites (1)

Lijun Xu

Zhenjiang, Hangzhou, 310020, China

Location

MeSH Terms

Conditions

Meningitis, Cryptococcal; Acquired Immunodeficiency Syndrome

Interventions

Voriconazole; amphotericin B, deoxycholate drug combination

Condition Hierarchy (Ancestors)

Meningitis, Fungal; Central Nervous System Fungal Infections; Mycoses; Bacterial Infections and Mycoses; Infections; Cryptococcosis; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lijun Xu, PH.D

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2019
• First Posted: August 28, 2019
• Study Start: January 25, 2021
• Primary Completion: July 31, 2022
• Study Completion: December 1, 2022
• Last Updated: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 12 months
• 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).

Locations

CN (1)