UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021930 |
|---|---|
| Receipt number | R000025241 |
| Scientific Title | Research about the relationship between neutrophil CD64 explession level in human immunodeficiency virus (HIV)-1 infected patients and the stage of HIV infection or immune reconstitution after the initiation of antiretroviral therapy |
| Date of disclosure of the study information | 2016/04/16 |
| Last modified on | 2016/04/15 23:32:10 |
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Basic information
Public title
Research about the relationship between neutrophil CD64 explession level in human immunodeficiency virus (HIV)-1 infected patients and the stage of HIV infection or immune reconstitution after the initiation of antiretroviral therapy
Acronym
Relationship between neutrophil CD64 in HIV-1 infected patients and the stage of HIV infection or immune reconstitution after the initiation of ART
Scientific Title
Research about the relationship between neutrophil CD64 explession level in human immunodeficiency virus (HIV)-1 infected patients and the stage of HIV infection or immune reconstitution after the initiation of antiretroviral therapy
Scientific Title:Acronym
Relationship between neutrophil CD64 in HIV-1 infected patients and the stage of HIV infection or immune reconstitution after the initiation of ART
Region
| Japan |
Condition
Condition
HIV-1 infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the absolute neutrophil CD64 expression levels (nCD64) before and after the initiation of ART and to determine the utility of nCD64 as an infammation marker of HIV-1 infection
Basic objectives2
Others
Basic objectives -Others
Utility
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
absolute neutrophil CD64 expression level before and after the initiation of ART
Key secondary outcomes
1.HIV infection marker before and after the initiation of ART (CD4 and CD8 T lymphocyte count and HIV RNA level)
2.Onset of the immune reconstitution inflammatory syndrome
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
| 0 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
HIV-1 infected patients
Key exclusion criteria
The patients who does not want to join this study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihiro Furusyo |
Organization
Kyusyu University Hospital
Division name
Department of General Internal Medicine
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
TEL
092-642-5909
furusyo@gim.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Murata |
Organization
Kyushu University Hospital
Division name
Department of General Internal Medicine
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
TEL
092-642-5909
Homepage URL
mmurata@gim.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of General Internal Medicine, Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of General Internal Medicine, Kyushu 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
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
24-151
Org. issuing International ID_1
Kyushu University ethics committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 16 | 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
| 2012 | Year | 12 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The neutrophil CD64 expression level would be useful as a marker of systemic inflammation associated with HIV infection.
Management information
Registered date
| 2016 | Year | 04 | Month | 15 | Day |
Last modified on
| 2016 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025241
