UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014818
Receipt number R000017227
Scientific Title Evaluation of (1->3)-Beta-D-Glucan as a Diagnostic Tool for HIV associated Pneumocystis Pneumonia
Date of disclosure of the study information 2014/08/11
Last modified on 2018/10/11 22:25:34

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Basic information

Public title

Evaluation of (1->3)-Beta-D-Glucan as a Diagnostic Tool for HIV associated Pneumocystis Pneumonia

Acronym

HIV-BG

Scientific Title

Evaluation of (1->3)-Beta-D-Glucan as a Diagnostic Tool for HIV associated Pneumocystis Pneumonia

Scientific Title:Acronym

HIV-BG

Region

Japan


Condition

Condition

HIV associated Pneumocystis pneumonia (PCP)

Classification by specialty

Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate (1->3)-beta-D-glucan (BG) as a diagnostic tool for HIV associated PCP.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To demonstrate the characteristics of BG as a diagnostic tool for HIV associated PCP.

Key secondary outcomes

To assess the influence of patient's background, HIV status (CD4 count, viral load), other concurrent opportunistic infections and complicating illnesses on the performance of BG.


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

Medicine

Interventions/Control_1

To measure BG.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. New HIV patients.
2. HIV patients who are diagnosed as PCP.

Key exclusion criteria

1. Patients who do not consent to join this study.
2. Patients who cannot understand the explanation of this study because of impaired consciousness or mental problem.
3. Patients who are considered as inappropriate for this study by investigators.

Target sample size

180


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Katsuji Teruya

Organization

National Center for Global Health and Medicine

Division name

AIDS Clinical Center

Zip code


Address

1-21-1, Toyama, Shinjuku-ku, Tokyo, JAPAN

TEL

+81-3-3202-7181

Email

kteruya@acc.ncgm.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Taiichiro Kobayashi

Organization

National Center for Global Health and Medicine

Division name

AIDS Clinical Center

Zip code


Address

1-21-1, Toyama, Shinjuku-ku, Tokyo, JAPAN

TEL

+81-3-3202-7181

Homepage URL


Email

tkobayashi@cick.jp


Sponsor or person

Institute

National Center for Global Health and Medicine

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

国立国際医療研究センター病院 エイズ治療・研究開発センター(東京都)


Other administrative information

Date of disclosure of the study information

2014 Year 08 Month 11 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Main results already published

Date of protocol fixation

2014 Year 08 Month 11 Day

Date of IRB


Anticipated trial start date

2014 Year 08 Month 11 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 08 Month 11 Day

Last modified on

2018 Year 10 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017227


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name