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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021930
Receipt No. R000025241
Scientific Title Research about the relationship between neutrophil CD64 explession level in human immunodeficiency virus (HIV)-1 infected patients and the stage of HIV infection or immune reconstitution after the initiation of antiretroviral therapy
Date of disclosure of the study information 2016/04/16
Last modified on 2016/04/15

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Basic information
Public title Research about the relationship between neutrophil CD64 explession level in human immunodeficiency virus (HIV)-1 infected patients and the stage of HIV infection or immune reconstitution after the initiation of antiretroviral therapy
Acronym Relationship between neutrophil CD64 in HIV-1 infected patients and the stage of HIV infection or immune reconstitution after the initiation of ART
Scientific Title Research about the relationship between neutrophil CD64 explession level in human immunodeficiency virus (HIV)-1 infected patients and the stage of HIV infection or immune reconstitution after the initiation of antiretroviral therapy
Scientific Title:Acronym Relationship between neutrophil CD64 in HIV-1 infected patients and the stage of HIV infection or immune reconstitution after the initiation of ART
Region
Japan

Condition
Condition HIV-1 infection
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the absolute neutrophil CD64 expression levels (nCD64) before and after the initiation of ART and to determine the utility of nCD64 as an infammation marker of HIV-1 infection
Basic objectives2 Others
Basic objectives -Others Utility
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes absolute neutrophil CD64 expression level before and after the initiation of ART
Key secondary outcomes 1.HIV infection marker before and after the initiation of ART (CD4 and CD8 T lymphocyte count and HIV RNA level)
2.Onset of the immune reconstitution inflammatory syndrome

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
0 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria HIV-1 infected patients
Key exclusion criteria The patients who does not want to join this study
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihiro Furusyo
Organization Kyusyu University Hospital
Division name Department of General Internal Medicine
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
TEL 092-642-5909
Email furusyo@gim.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayuki Murata
Organization Kyushu University Hospital
Division name Department of General Internal Medicine
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
TEL 092-642-5909
Homepage URL
Email mmurata@gim.med.kyushu-u.ac.jp

Sponsor
Institute Department of General Internal Medicine, Kyushu University Hospital
Institute
Department

Funding Source
Organization Department of General Internal Medicine, Kyushu University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 24-151
Org. issuing International ID_1 Kyushu University ethics committee
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 16 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 12 Month 14 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 14 Day
Last follow-up date
2014 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The neutrophil CD64 expression level would be useful as a marker of systemic inflammation associated with HIV infection.

Management information
Registered date
2016 Year 04 Month 15 Day
Last modified on
2016 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025241

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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