UMIN-CTR Clinical Trial

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
Institute	HIV infection Medical Support Center, Hokkaido University Hospital
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038346