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
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
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
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
