UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015357
Receipt number R000017863
Scientific Title The multicenter observational study for the prevalence of HIV-associated neurocognitive disorder (HAND) in Japan
Date of disclosure of the study information 2014/10/08
Last modified on 2017/05/10 10:42:08

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Basic information

Public title

The multicenter observational study for the prevalence of HIV-associated neurocognitive disorder (HAND) in Japan

Acronym

J-HAND study

Scientific Title

The multicenter observational study for the prevalence of HIV-associated neurocognitive disorder (HAND) in Japan

Scientific Title:Acronym

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

1st name
Middle name
Last name Ei Kinai

Organization

National Center for Global Health and Medicine

Division name

AIDS Clinical Center

Zip code


Address

1-21-1, Toyama, Shinjuku-ku, Tokyo

TEL

03-3202-7181

Email

ekinai@acc.ncgm.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ei Kinai

Organization

National Center for Global Health and Medicine

Division name

AIDS Clinical Center

Zip code


Address

1-21-1, Toyama, Shinjuku-ku, Tokyo

TEL

03-3202-7181

Homepage URL


Email

ekinai@acc.ncgm.go.jp


Sponsor or person

Institute

AIDS Clinical Center , National Center for Global Health and Medicine

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 06 Month 27 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017863


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name