UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021201 |
|---|---|
| Receipt number | R000024430 |
| Scientific Title | Clinical investigation of HIV infection diagnostic kit |
| Date of disclosure of the study information | 2016/02/26 |
| Last modified on | 2016/07/04 12:30:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinical investigation of HIV infection diagnostic kit
Acronym
Clinical investigation of HIV infection diagnostic kit
Scientific Title
Clinical investigation of HIV infection diagnostic kit
Scientific Title:Acronym
Clinical investigation of HIV infection diagnostic kit
Region
| Japan |
Condition
Condition
HIV infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate HIV antibody and antigen test
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concordance between new test and western-blot analysis
Key secondary outcomes
Concordance between new test and HIV-antibody test which is used for HIV infection screening
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Comparison between conventional method and new test
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
Disease group
1) Patient with HIV infection.
2) Enable to obtain the written informed consent.
Healthy group
1) HIV-non infected.
Key exclusion criteria
Disease group
1) Patient who have been infected for HIV within one month.
2) Unable to have sighed informed consent.
3) Patients whose phycian consider the study enrollment inappropreate.
Healthy group
1) HIV infected
2) Uncontrolled diabetes
3) Tumor-bearing
4) Taking immunosuppressive drug
5) Patients whose physician consider the study enrollment inappropreate
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Haseagwa |
Organization
Keio University School of Medicine
Division name
Centor for Infectious Diseases and Infection Control
Zip code
Address
Shinanomachi 35 Shinjyuku-ku Tokyo
TEL
03-3353-1211
lecafe1979@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Kato |
Organization
Keio University School of Medicine
Division name
Department of Microbiology and Immunology
Zip code
Address
Shinanomachi 35 Shinjyuku-ku Tokyo
TEL
03-3353-1211
Homepage URL
skato@a3.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Center for Infectious Disease and Infection Control
Institute
Department
Personal name
Funding Source
Organization
Department of Microbiology and Immunology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kanagawa Prefectural Institute of Public Health
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 02 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Concordance between new test and western-blot analysis and new test and HIV-antibody test which is used for HIV infection screening
Management information
Registered date
| 2016 | Year | 02 | Month | 25 | Day |
Last modified on
| 2016 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024430
