UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001088 |
|---|---|
| Receipt number | R000001316 |
| Scientific Title | The association of CD4 cell counts at HIV diagnosis with characteristic, testing reason and medical history in Japanese. |
| Date of disclosure of the study information | 2008/03/19 |
| Last modified on | 2010/08/17 21:04:32 |
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Basic information
Public title
The association of CD4 cell counts at HIV diagnosis with characteristic, testing reason and medical history in Japanese.
Acronym
The association of CD4 cell counts at HIV diagnosis with characteristic, testing reason and medical history in Japanese.
Scientific Title
The association of CD4 cell counts at HIV diagnosis with characteristic, testing reason and medical history in Japanese.
Scientific Title:Acronym
The association of CD4 cell counts at HIV diagnosis with characteristic, testing reason and medical history in Japanese.
Region
| Japan |
Condition
Condition
HIV infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the characteristic of HIV infected patients who have CD4 cell counts 200/mm3 or more at HIV diagnosis
Basic objectives2
Others
Basic objectives -Others
Relationship
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association between patients characteristic and CD4 cell counts at HIV diagnosis.
The association between HIV testing reason and CD4 cell counts at HIV diagnosis.
Key secondary outcomes
The frequency of HIV-related disease or symptoms before HIV diagnosis.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) HIV infected patients
2) Patients who live in Japan
3) Patients who had had a check-up at the AIDS Clinical Center, International Medical Center of Japan
Key exclusion criteria
1) HIV Infected patients by mother-to-child transmission
2) HIV Infected patients by blood products
3) HIV Infected patients by accident
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukiko Wagatsuma |
Organization
University of Tsukuba
Division name
Graduate School of Comprehensive Human Sciences, Doctoral Program in Social and Environmental Medicine, Department of Epidemiology
Zip code
Address
Tennodai, Tsukuba, 305-8575 Ibaraki, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Center for Global Health and Medicine
Division name
AIDS Clinical Center
Zip code
Address
TEL
Homepage URL
mtakano@acc.ncgm.go.jp
Sponsor or person
Institute
Graduate School of Comprehensive Human Sciences, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
独立行政法人 国立国際医療研究センター病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 03 | Month | 19 | 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
| 2003 | Year | 10 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 10 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
1) Retrospective observational study
2) The data elements are captured from the medical record review.
Management information
Registered date
| 2008 | Year | 03 | Month | 19 | Day |
Last modified on
| 2010 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001316
