Comparative Study of Human Immunodeficiency Virus Negative Host Talaromyces Between Voriconazole and Amphotericin Sequential Itraconazole Therapy (CSHHTVASIT)

G

Guangxi Medical University

Status

Unknown

Conditions

Talaromyces in Human Immunodeficiency Virus Negative
To Compare Voriconazole and Amphotericin Sequential Itraconazole Therapy
To Dynamically Monitor the Anti-Interferon-γ Autoantibodies

Treatments

Drug: Voriconazole

Study type

Interventional

Funder types

Other

Identifiers

NCT03827278
TSM-AMB-VOR-2018

Details and patient eligibility

About

Through a multi-center large-sample non-randomized controlled study, the effect of voriconazole, amphotericin B sequential itraconazole therapy on Talaromyces in Human Immunodeficiency Virus(HIV)negative hosts were compared to clarify whether the two therapies were equivalent; A comprehensive efficacy evaluation system and standard treatment program was established to provide a basis for standardized treatment of Talaromyces in Human Immunodeficiency Virus negative hosts.The observational indicators included: 2-week all-cause mortality; 24-week all-cause mortality; clinical improvement time; level of decrease of fungus in the blood culture medium two weeks before treatment; recurrence; appearance of adverse drug reaction at the level 3 and above. Dynamically monitor the immune cells and factors like anti-Interferon-γ autoantibodies, Interferon-γ, Th1/Th2, and Th17/Treg in the HIV-negative Talaromyces host microenvironment, and observe the host's immune status and its change. 3. study the effect of absence of Interferon-γ and Interferon-γ Receptor (IFN-γR)on the activation and function of anti-Interferon-γ autoantibodies, Th1/Th2, and Th17/Treg by establishing a Talaromyces mouse model that knocks out the Interferon-γ and IFN-γR gene and a IFN-γ silenced cell model; Study the effect of anti-IFN-γ autoantibody on the activation and function of IFN-γ、Th1/Th2、Th17/Treg by increasing its titer in vitro and vivo; determine by which path the anti-IFN-γ autoantibody of HIV-negative host influences its immune regulation mechanism; finally, the intervention effect of IFN-γ on high titer anti-IFN-γ autoantibodies is studied, providing a new idea for immunotargeted therapy.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • HIV-negative adults (≥18 years of age) who diagnosis of talaromyces that was confirmed by either microscopy or culture
  • Must be able to swallow tablets

Exclusion criteria

  • Pregnancy, central nervous system involvement assessed either clinically or by analyses of cerebrospinal fluid
  • An allergy to voriconazole, itraconazole or amphotericin
  • The concomitant use of certain medications that interact with voriconazole, itraconazole or amphotericin
  • An alanine aminotransferase or aspartate aminotransferase level of more than 400 U per liter
  • An absolute neutrophil count of less than 500 per cubic millimeter
  • A creatinine clearance of less than 30 ml per minute (calculated by the method of Cockcroft and Gault)
  • a concurrent diagnosis of cryptococcal meningitis
  • concurrent treatment with rifampicin
  • previous treatment for talaromyces for more than 48 hours
  • HIV positive who diagnosis of talaromyces.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

HIV Negative Host talaromyces using Voriconazole
Experimental group
Description:
Voriconazole On the first day, 6 mg/kg bid was given, and then 4 mg/kg bid was given intravenously for 6 days, and then oral voriconazole 200 mg bid was administered to maintain treatment for at least 6 months.
Treatment:
Drug: Voriconazole
HIV Negative talaromyces AMB Sequential Itraconazole
Experimental group
Description:
Amphotericin B (AMB) sequential itraconazole group (intravenous amphotericin, dose 0.7 - 1.0 mg / kg / d, 14 days, then changed oral itraconazole 200 mg bid for 10 weeks, after which 100 mg bid maintenance Until cluster of differentiation 4 (CD4+ T) cells are greater than 100 cells/L for at least 6 months
Treatment:
Drug: Voriconazole

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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