UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study for the prevalence of HIV-associated neurocognitive disorder (HAND) in HIV-infected hemophilia
Title of the study (Brief title)	Hemophilia/HAND study
Region	Japan

Condition
Condition	Hemophilia, HIV infection
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 of HIV-associated neurocognitive disorder in HIV-infected hemophilia
Basic objectives2	Others
Basic objectives -Others	Neuropsychological evaluation of HIV-infected hemophilia
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The prevalence of HIV-associated 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 severe 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	50

Research contact person
Name of lead principal investigator	Koubun Imai
Organization	National Center for Global Health and Medicine
Division name	Department of Psychiatry
Address	1-21-1, Toyama, Shinjuku-ku, Tokyo
TEL	03-3202-7181
Email	koimai@hosp.ncgm.go.jp

Public contact
Name of contact person	Koubun Imai
Organization	National Center for Global Health and Medicine
Division name	Department of Psychiatry
Address	1-21-1, Toyama, Shinjuku-ku, Tokyo
TEL	03-3202-7181
Homepage URL
Email	koimai@hosp.ncgm.go.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	AIDS Clinical Center, National Center for Global Health and Medicine
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	国立国際医療研究センター（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 22 Day
Anticipated trial start date	2016 Year 05 Month 01 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry	2018 Year 01 Month 31 Day
Date trial data considered complete	2018 Year 02 Month 28 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Neuropsychiatric examination, mental symptoms

Management information
Registered date	2016 Year 04 Month 04 Day
Last modified on	2019 Year 02 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025113