UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of (1->3)-Beta-D-Glucan as a Diagnostic Tool for HIV associated Pneumocystis Pneumonia
Title of the study (Brief title)	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	Katsuji Teruya
Organization	National Center for Global Health and Medicine
Division name	AIDS Clinical Center
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	Taiichiro Kobayashi
Organization	National Center for Global Health and Medicine
Division name	AIDS Clinical Center
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

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 08 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000017227