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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000014818
Receipt No. 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

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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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Institute National Center for Global Health and Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017227


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