UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011415 |
|---|---|
| Receipt number | R000013366 |
| Scientific Title | Brain magnetic resonance spectroscopy in Japanese HIV-infected patients |
| Date of disclosure of the study information | 2013/08/12 |
| Last modified on | 2017/02/09 09:08:19 |
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Basic information
Public title
Brain magnetic resonance spectroscopy in Japanese HIV-infected patients
Acronym
HIV-MRS study
Scientific Title
Brain magnetic resonance spectroscopy in Japanese HIV-infected patients
Scientific Title:Acronym
HIV-MRS study
Region
| Japan |
Condition
Condition
HIV infection
Classification by specialty
| Neurology | Infectious disease | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the metabolism in brain by MR spectroscopy in HIV-infected individuals and compare it with non-HIV infected individuals.
Basic objectives2
Others
Basic objectives -Others
To elucidate the pathogenesis of HIV-related neurocognitive disorder.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The levels of metabolites in brain: N-acetyl aspartate, creatinin, choline, lactate, and lipids, measured by MR spectroscopy.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
MR spectroscopy in brain
(for HIV-infected individuals on antiretroviral therapy)
Interventions/Control_2
MR spectroscopy in brain
(for HIV-infected individuals without antiretroviral therapy)
Interventions/Control_3
MR spectroscopy in brain
(for non-HIV-infected individuals)
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
A-1: HIV-infected individuals on antiretroviral therapy over 6 months
A-2: HIV-infected individuals without antiretroviral therapy within 6 months
B: non-HIV-infected individuals matched according to age and sex of Group A.
Key exclusion criteria
Individuals wiht any active disease in brain except HIV-related neurocognitive disorder, or any MRI contraindications.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junko Tanuma |
Organization
National Center for Global Health and Medicine
Division name
AIDS Clinical Center
Zip code
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
TEL
03-3202-7181
jtanuma@acc.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junko Tanuma |
Organization
National Center for Global Health and Medicine
Division name
AIDS Clinical Center
Zip code
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
TEL
03-3202-7181
Homepage URL
jtanuma@acc.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
The Grant of National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
独立行政法人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
| 2013 | Year | 08 | Month | 12 | 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
| 2010 | Year | 12 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 08 | Day |
Last modified on
| 2017 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013366
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
