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Trial record 4 of 205 for:    SPORANOX I.V. OR ITRACONAZOLE OR ONMEL OR SPORANOX-PULSE OR Sporanos OR R 51,211 OR SPORANOX

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

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ClinicalTrials.gov Identifier: NCT03827278
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : February 5, 2019
Sponsor:
Collaborators:
First Affiliated Hospital of Guangxi Medical University
Second Affiliated Hospital of Guangzhou Medical University
The Fourth People’s Hospital of Nanning
Guilin Medical College
Nanning Second People's Hospital
Information provided by (Responsible Party):
Qiu Ye, Guangxi Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Talaromyces in Human Immunodeficiency Virus Negative To Compare Voriconazole and Amphotericin Sequential Itraconazole Therapy To Dynamically Monitor the Anti-Interferon-γ Autoantibodies Drug: Voriconazole Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Human Immunodeficiency Virus Negative Host Talaromyces Between Voriconazole and Amphotericin B Sequential Itraconazole Therapy
Actual Study Start Date : December 30, 2018
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: HIV Negative Host talaromyces using Voriconazole
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.
Drug: Voriconazole

6mg/kg bid, was given on the first day, followed by intravenous 4mg/kg bid for 6 days, followed by oral Valconazole 200mg bid for at least 6 months.

Amphotericin B 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 CD4+ T cells are greater than 100 cells/L for at least 6 months

Other Names:
  • Amphotericin
  • Itraconazole

Experimental: HIV Negative talaromyces AMB Sequential Itraconazole
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
Drug: Voriconazole

6mg/kg bid, was given on the first day, followed by intravenous 4mg/kg bid for 6 days, followed by oral Valconazole 200mg bid for at least 6 months.

Amphotericin B 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 CD4+ T cells are greater than 100 cells/L for at least 6 months

Other Names:
  • Amphotericin
  • Itraconazole




Primary Outcome Measures :
  1. Number of Participants with all-cause mortality [ Time Frame: up to 2 weeks ]
    defined as the absolute risk of death from any cause during the first 2 weeks

  2. Number of Participants with all-cause mortality [ Time Frame: up to 24 weeks ]
    defined as the absolute risk of death from any cause during 24 weeks

  3. Number of Participants with Clinical resolution of talaromyces [ Time Frame: 3 days ]
    Clinical resolution of talaromyces was defined as a temperature of less than 38°C (100°F) for 3 days, resolution of skin lesions, and tertile blood cultures. Early fungicidal activity was defined as the rate of decline in blood T. marneffei colony forming units (CFUs).

  4. Number of Participants with Early fungicidal activity [ Time Frame: up to 2 weeks ]
    defined as the rate of decline in blood T. marneffei CFUs from sterical blood cultures obtained during the first 2 weeks.

  5. Number of Participants with Relapse of talaromyces [ Time Frame: an average of 1 year ]
    defined as the recurrence of symptoms and a positive fungal culture from any sterile site that led to reinduction of therapy in patients who had achieved clinical resolution.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827278


Locations
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China, Guangxi
Guangxi Medical University Recruiting
Nanning, Guangxi, China, 530021
Contact: Ye Qiu, M.D    0771-5356702    yeqiu2013graduated@163.com   
Principal Investigator: Jianquan Zhang, Professor         
Sub-Investigator: Wen Zen, M.D         
Sub-Investigator: Hui Zhang, M.D         
Sub-Investigator: Mianluan Pan, M.D         
Sub-Investigator: Shudan Tang, M.D         
Sub-Investigator: Yanping Tang, M.D         
Sub-Investigator: Haiguang Xu, M.D         
Sub-Investigator: Jie Huang, M.D         
Sub-Investigator: Xin Feng, M.D         
Principal Investigator: Ye Qiu, M.D         
Sub-Investigator: Haiting Qin, M.D         
Sub-Investigator: Minchao Duan, M.D         
Sponsors and Collaborators
Guangxi Medical University
First Affiliated Hospital of Guangxi Medical University
Second Affiliated Hospital of Guangzhou Medical University
The Fourth People’s Hospital of Nanning
Guilin Medical College
Nanning Second People's Hospital

Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site

Publications of Results:
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Responsible Party: Qiu Ye, Clinical Professor, Guangxi Medical University
ClinicalTrials.gov Identifier: NCT03827278     History of Changes
Other Study ID Numbers: TSM-AMB-VOR-2018
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Qiu Ye, Guangxi Medical University:
Talaromyces
voriconazole
Amphotericin Sequential Itraconazole therapy
anti-Interferon-γ autoantibodies

Additional relevant MeSH terms:
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Itraconazole
Hydroxyitraconazole
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Voriconazole
Amphotericin B
Liposomal amphotericin B
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Amebicides
Antiprotozoal Agents
Antiparasitic Agents