UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The multicenter observational study for the prevalence of HIV-associated neurocognitive disorder (HAND) in Japan
Title of the study (Brief title)	J-HAND study
Region	Japan

Condition
Condition	HIV-associated neurocognitive disorder
Classification by specialty	Neurology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	An evaluation of the prevalence of HIV-associated neurocognitive disorders in Japan
Basic objectives2	Others
Basic objectives -Others	An evaluation of risk and confounding factors for HIV-associated neurocognitive disorders
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The prevalence of HIV-associated neurocognitive disorder in Japan
Key secondary outcomes	The evaluation of risk and confounding factors for neuropsychiatric scores.

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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) HIV-infected patients (2) older than 20 years old (3) Japanese (4) Written informed consent
Key exclusion criteria	Active AIDS-defining disease. Congenital developmental retardation Definitive diagnosis of following diseases; Mental disorder, such as major depressive disorder, schizophrenia. Alzheimer's disease, Frontotemporallobar degeneration, Lewy-body disease, Vascular disease, Traumatic brain injury, Prion disease, Parkinson's disease, Huntington's disease. Another functional disorder (Epilepsy) Illegal substance use Severe alcoholism Endocrine disorder (hypothyroidism, Wernicke encephalopathy, Vitamin B12 deficiency) Current treatment or severe sequelae of CNS opportunistic infections Symptoms of a current, active infection a body temperature of >38.5 at the time of recruitment Experience of neuropsychiatric test within past 1 year Other inappropriate condition for neuropsychiatric test
Target sample size	500

Research contact person
Name of lead principal investigator	Ei Kinai
Organization	National Center for Global Health and Medicine
Division name	AIDS Clinical Center
Address	1-21-1, Toyama, Shinjuku-ku, Tokyo
TEL	03-3202-7181
Email	ekinai@acc.ncgm.go.jp

Public contact
Name of contact person	Ei Kinai
Organization	National Center for Global Health and Medicine
Division name	AIDS Clinical Center
Address	1-21-1, Toyama, Shinjuku-ku, Tokyo
TEL	03-3202-7181
Homepage URL
Email	ekinai@acc.ncgm.go.jp

Sponsor
Institute	AIDS Clinical Center , National Center 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	National Kyushu Medical Center Ehime University Hospital Kawasaki Medical School Hospital Niigata City General Hospital
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	国立病院機構九州医療センター（福岡県）、愛媛大学医学部附属病院（愛媛県）、川崎医科大学附属病院（岡山県）、新潟市民病院（新潟県）

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 27 Day
Anticipated trial start date	2014 Year 07 Month 22 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry	2017 Year 01 Month 31 Day
Date trial data considered complete	2017 Year 02 Month 28 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	An evaluation of risk factors and confounding factors for HIV-associated neurocognitive disorders.

Management information
Registered date	2014 Year 10 Month 07 Day
Last modified on	2017 Year 05 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017863