UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	FDG PET brain images of the patients with HIV
Title of the study (Brief title)	FDG PET brain images of the patients with HIV
Region	Japan

Condition
Condition	HIV related disease
Classification by specialty	Neurology Infectious disease Psychiatry Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the utility of 18F-FDG PET for diagnosis of HIV related cognitive disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	18F-FDG PET could detect the mild cognitive disorder of the patients with HIV.
Key secondary outcomes

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

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male
Key inclusion criteria	1. HIV positive 2.age>20 years old. 3.capabity to have PET scan 4.completed the written infrmed consent.
Key exclusion criteria	1.unable to have signed infrmed consent. 2.Patients with severe underlying disease haveing risk of liver dysfunction, renal dysfunction and any metabolic damage. 3.just after surgery and/or brain trauma 4.uncontrolled diabeics 5.Those who are determined as not appropriate for the study by physician in chief.
Target sample size	80

Research contact person
Name of lead principal investigator	Ryogo Minamimoto
Organization	National Center for Global Health and Medicine
Division name	Radiology
Address	1-21-1,Toyama, Shinjuku, Tokyo, Japan
TEL	03-3202-7181
Email	rminamimoto@hosp.ncgm.go.jp

Public contact
Name of contact person	Ryogo Minamimoto
Organization	National Center for Global Health and Medicine
Division name	Radiology
Address	1-21-1, Toyama, Shinjuku, Tokyo
TEL	03-3202-7181
Homepage URL
Email	rinrijm@hosp.ncgm.go.jp

Sponsor
Institute	National Centerf for Global Health and Medicine.
Institute
Department

Funding Source
Organization	National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor	Tokyo Metroporitan institue for Genontology.
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	2012 Year 07 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 01 Month 25 Day
Anticipated trial start date	2012 Year 07 Month 25 Day
Last follow-up date	2017 Year 04 Month 07 Day
Date of closure to data entry	2017 Year 04 Month 07 Day
Date trial data considered complete	2017 Year 04 Month 07 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	FDG PET, MRI, and the neuropsychological tests are performed and the findings are compared to normal.

Management information
Registered date	2012 Year 07 Month 24 Day
Last modified on	2017 Year 05 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010007