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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name