UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021773 |
|---|---|
| Receipt number | R000025113 |
| Scientific Title | The study for the prevalence of HIV-associated neurocognitive disorder (HAND) in HIV-infected hemophilia |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2019/02/22 18:56:12 |
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Basic information
Public title
The study for the prevalence of HIV-associated neurocognitive disorder (HAND) in HIV-infected hemophilia
Acronym
Hemophilia/HAND study
Scientific Title
The study for the prevalence of HIV-associated neurocognitive disorder (HAND) in HIV-infected hemophilia
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Koubun Imai |
Organization
National Center for Global Health and Medicine
Division name
Department of Psychiatry
Zip code
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo
TEL
03-3202-7181
koimai@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koubun Imai |
Organization
National Center for Global Health and Medicine
Division name
Department of Psychiatry
Zip code
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo
TEL
03-3202-7181
Homepage URL
koimai@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2016 | Year | 03 | Month | 22 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025113
