UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research about the relationship between neutrophil CD64 explession level in human immunodeficiency virus (HIV)-1 infected patients and the stage of HIV infection or immune reconstitution after the initiation of antiretroviral therapy
Title of the study (Brief title)	Relationship between neutrophil CD64 in HIV-1 infected patients and the stage of HIV infection or immune reconstitution after the initiation of ART
Region	Japan

Condition
Condition	HIV-1 infection
Classification by specialty	Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the absolute neutrophil CD64 expression levels (nCD64) before and after the initiation of ART and to determine the utility of nCD64 as an infammation marker of HIV-1 infection
Basic objectives2	Others
Basic objectives -Others	Utility
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	absolute neutrophil CD64 expression level before and after the initiation of ART
Key secondary outcomes	1.HIV infection marker before and after the initiation of ART (CD4 and CD8 T lymphocyte count and HIV RNA level) 2.Onset of the immune reconstitution inflammatory syndrome

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	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	0 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	HIV-1 infected patients
Key exclusion criteria	The patients who does not want to join this study
Target sample size	80

Research contact person
Name of lead principal investigator	Norihiro Furusyo
Organization	Kyusyu University Hospital
Division name	Department of General Internal Medicine
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
TEL	092-642-5909
Email	furusyo@gim.med.kyushu-u.ac.jp

Public contact
Name of contact person	Masayuki Murata
Organization	Kyushu University Hospital
Division name	Department of General Internal Medicine
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
TEL	092-642-5909
Homepage URL
Email	mmurata@gim.med.kyushu-u.ac.jp

Sponsor
Institute	Department of General Internal Medicine, Kyushu University Hospital
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 General Internal Medicine, Kyushu University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	24-151
Org. issuing International ID_1	Kyushu University ethics committee
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 04 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 12 Month 14 Day
Anticipated trial start date	2012 Year 12 Month 14 Day
Last follow-up date	2014 Year 04 Month 30 Day
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	The neutrophil CD64 expression level would be useful as a marker of systemic inflammation associated with HIV infection.

Management information
Registered date	2016 Year 04 Month 15 Day
Last modified on	2016 Year 04 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025241