UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical investigation of HIV infection diagnostic kit
Title of the study (Brief title)	Clinical investigation of HIV infection diagnostic kit
Region	Japan

Condition
Condition	HIV infection
Classification by specialty	Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate HIV antibody and antigen test
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Concordance between new test and western-blot analysis
Key secondary outcomes	Concordance between new test and HIV-antibody test which is used for HIV infection screening

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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Comparison between conventional method and new test
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Disease group 1) Patient with HIV infection. 2) Enable to obtain the written informed consent. Healthy group 1) HIV-non infected.
Key exclusion criteria	Disease group 1) Patient who have been infected for HIV within one month. 2) Unable to have sighed informed consent. 3) Patients whose phycian consider the study enrollment inappropreate. Healthy group 1) HIV infected 2) Uncontrolled diabetes 3) Tumor-bearing 4) Taking immunosuppressive drug 5) Patients whose physician consider the study enrollment inappropreate
Target sample size	200

Research contact person
Name of lead principal investigator	Naoki Haseagwa
Organization	Keio University School of Medicine
Division name	Centor for Infectious Diseases and Infection Control
Address	Shinanomachi 35 Shinjyuku-ku Tokyo
TEL	03-3353-1211
Email	lecafe1979@yahoo.co.jp

Public contact
Name of contact person	Shingo Kato
Organization	Keio University School of Medicine
Division name	Department of Microbiology and Immunology
Address	Shinanomachi 35 Shinjyuku-ku Tokyo
TEL	03-3353-1211
Homepage URL
Email	skato@a3.keio.jp

Sponsor
Institute	Keio University School of Medicine Center for Infectious Disease and Infection Control
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	Department of Microbiology and Immunology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kanagawa Prefectural Institute of Public Health
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

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 26 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 02 Month 25 Day
Anticipated trial start date	2016 Year 03 Month 01 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	Unpublished
URL releasing results
Results
Other related information	Concordance between new test and western-blot analysis and new test and HIV-antibody test which is used for HIV infection screening

Management information
Registered date	2016 Year 02 Month 25 Day
Last modified on	2016 Year 07 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024430