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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034065
Receipt No. R000038834
Scientific Title The diagnosis of latent tuberculosis infection in the patients of HIV infection
Date of disclosure of the study information 2018/09/08
Last modified on 2018/09/07

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Basic information
Public title The diagnosis of latent tuberculosis infection in the patients of HIV infection
Acronym HIV and LTBI
Scientific Title The diagnosis of latent tuberculosis infection in the patients of HIV infection
Scientific Title:Acronym HIV and LTBI
Region
Japan

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

Objectives
Narrative objectives1 To estimate the prevalence of latent tuberculosis infection by using QFT-Plus and TSPOT in the patients of HIV infection
Basic objectives2 Others
Basic objectives -Others To analyze the effects of CD4 T-cell and CD8 Tcell on the diagnosis of QFT-Plus and TSPOT
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The positivity rate in QFT-Plus and TSPOT
Key secondary outcomes The relation between the interferon-gamma production in QFT and TSPOT and the lymphocyte subset (CD4 T-cell and CD8 Tcell) counts

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 The tuberculosis diagnosis by using QFT-Plus and TSPOT, One time
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
20 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria HIV infection
Key exclusion criteria inappropriate case
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidetoshi Igari
Organization Chiba University Hospital
Division name Division of Infection Control
Zip code
Address 1-8-1 Inohana Chuo-ku, Chiba 260-8677, Japan
TEL 0432262661
Email igari_h@chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidetoshi Igari
Organization Chiba University Hospital
Division name Division of Infection Control
Zip code
Address 1-8-1 Inohana Chuo-ku, Chiba 260-8677, Japan
TEL 0432262661
Homepage URL
Email igari_h@chiba-u.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization The Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Chiba Foundation for Health Promotion and Disease Prevention
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 08 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 Preinitiation
Date of protocol fixation
2018 Year 05 Month 17 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 10 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 07 Day
Last modified on
2018 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038834

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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