UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034065 |
|---|---|
| Receipt number | 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 | 2024/03/12 11:20:43 |
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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 | Hidetoshi |
| Middle name | |
| Last name | Igari |
Organization
Chiba University Hospital
Division name
Division of Infection Control
Zip code
260-8677
Address
1-8-1 Inohana Chuo-ku, Chiba 260-8677, Japan
TEL
0432262661
igari_h@chiba-u.jp
Public contact
Name of contact person
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Igari |
Organization
Chiba University Hospital
Division name
Division of Infection Control
Zip code
260-8677
Address
1-8-1 Inohana Chuo-ku, Chiba 260-8677, Japan
TEL
0432262661
Homepage URL
igari_h@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
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
Chiba Univetsity Hospital
Address
1-8-1 Inohana Chuo-ku, Chiba 260-8677, Japan
Tel
043-222-7171
igari_h@chiba-u.jp
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
none
Publication of results
Published
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
184
Results
One hundred eight-four subjects were prospectively enrolled. Median age was 49 years. The positivity rates of QFT-Plus and TSPOT were 7.6% [95%CI 4.6-12.4] and 2.7% [95%CI 1.2-6.2], respectively, with significant difference. TB-associated risk factors and NK cells >=300/microL were selected as independently significant factors by multivariate logistic regression. The NK cell count revealed significant linear regression with IFN-gamma production responding to TB-specific antigens.
Results date posted
| 2024 | Year | 03 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
HIV-positive patients
Participant flow
Two IGRAs (Interferon (IFN)-gamma release assays), QuantiFERON-TB Gold Plus (QFT-Plus) and T-Spot.TB (TSPOT), were used. We also analyzed the TB associated risk factors for the IGRAs results and the role of CD4+ T-cells, CD8+ T-cells and NK cells for producing IFN-gamma. We also analyzed the risk factors for positive IGRA responses and the role of CD4+ T-cells, CD8+ T-cells and NK cells for producing IFN-gamma.
Adverse events
None
Outcome measures
IGRA Positivity rate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 17 | Day |
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
| 2024 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038834
