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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001088
Receipt No. 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

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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
Email

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
Email mtakano@acc.ncgm.go.jp

Sponsor
Institute Graduate School of Comprehensive Human Sciences, University of Tsukuba
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001316

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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