UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033632
Receipt number R000038346
Scientific Title Study of evaluation of neurocognitive function and psycho-social problem in HIV-infected hemophilia
Date of disclosure of the study information 2018/09/01
Last modified on 2020/12/04 10:43:15

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Basic information

Public title

Study of evaluation of neurocognitive function and psycho-social problem in HIV-infected hemophilia

Acronym

Study of dimentia & mental health in HIV-infected hemophilia

Scientific Title

Study of evaluation of neurocognitive function and psycho-social problem in HIV-infected hemophilia

Scientific Title:Acronym

Study of dimentia & mental health in HIV-infected hemophilia

Region

Japan


Condition

Condition

Hemophilia, HIV infection, neurocognitive disorder

Classification by specialty

Hematology and clinical oncology Neurology Infectious disease
Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

An evaluation of the prevalence and severity of neurocognitive disorder in HIV-infected hemophilia

Basic objectives2

Others

Basic objectives -Others

Neuropsychological evaluation in HIV-infected hemophilia and compairisons with data of patients sexually transmitted HIV

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

The prevalence and severity of neurocognitive disorder in HIV-infected hemophilia

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


Not applicable

Gender

Male and Female

Key inclusion criteria

(1)HIV-infected hemophilia, (2)Older than 20 years old, (3)Written informed consent

Key exclusion criteria

(1)Active AIDS-defining disease
(2)Congenital developmental retardation
(3)Definitive diagnosis of following diseases
a. Mental disorder: major depressive disorder, schizophrenia
b. Alzheimer's disease, Frontotemporallobar degeneration, Lewy-body disease, Vascular disease, Traumatic brain injury, Prion disease, Parkinson's disease, Huntington's disease
c. Another functional neurocognitive disorder
d. Illegal substance use
e. Severe alcoholism
f. Endocrine disorder: hypothyroidism, Wernicke encephalopathy, Vitamin B12 deficiency
g. Current treatment or sever sequelae of CNS opportunistic infections
h. Symptoms of a current, active infection a body temperature of >38.5 at the time of recruitment
(4)Experience of neuropsychiatric test within past 1 year
(5)Other inappropriate condition for neuropsychiatric test

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Tomoyuki
Middle name
Last name Endo

Organization

Hokkaido University Hospital

Division name

Department of blood

Zip code

060-8648

Address

Kita 14, Nishi 5, Kita-ku, Sapporo, 060-8648, Japan

TEL

011-706-7025

Email

t-endo@med.hokudai.ac.jp


Public contact

Name of contact person

1st name Yoko
Middle name
Last name Ishida

Organization

Hokkaido University Hospital

Division name

HIV infection Medical Support Center

Zip code

060-8648

Address

Kita 14, Nishi 5, Kita-ku, Sapporo, 060-8648, Japan

TEL

011-706-7025

Homepage URL


Email

issi3@huhp.hokudai.ac.jp


Sponsor or person

Institute

HIV infection Medical Support Center, Hokkaido University Hospital

Institute

Department

Personal name



Funding Source

Organization

HIV infection Medical Support Center, Hokkaido University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Clinical Research and Medical Innovation Center

Address

Kita 14, Nishi 5, Kita-ku, Sapporo, 060-8648, Japan

Tel

011-706-7977

Email

issi3@huhp.hokudai.ac.jp


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

2018 Year 09 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

15

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events

None

Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 11 Month 26 Day

Date of IRB

2018 Year 11 Month 30 Day

Anticipated trial start date

2018 Year 11 Month 30 Day

Last follow-up date

2019 Year 12 Month 30 Day

Date of closure to data entry

2019 Year 12 Month 31 Day

Date trial data considered complete

2019 Year 12 Month 31 Day

Date analysis concluded

2020 Year 06 Month 30 Day


Other

Other related information

Neuropsycgiatric examination


Management information

Registered date

2018 Year 08 Month 03 Day

Last modified on

2020 Year 12 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038346


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name