UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004720 |
|---|---|
| Receipt number | R000005497 |
| Scientific Title | Neutralizing antibodies and clinical isolates of human immunodeficiency viruses (HIV). |
| Date of disclosure of the study information | 2010/12/14 |
| Last modified on | 2010/12/14 13:11:33 |
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Basic information
Public title
Neutralizing antibodies and clinical isolates of human immunodeficiency viruses (HIV).
Acronym
Neutralizing antibodies and clinical isolates ofHIV.
Scientific Title
Neutralizing antibodies and clinical isolates of human immunodeficiency viruses (HIV).
Scientific Title:Acronym
Neutralizing antibodies and clinical isolates ofHIV.
Region
| Japan |
Condition
Condition
HIV infection
Classification by specialty
| Hematology and clinical oncology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishment and characterization of neutralizing monoclonal antibodies (nMAbs) from patients with HIV-infection. To analyze sensitivity to nMAbs and anti-viral agents recent clinical isolates will obtained from patients with HIV-infection.
Basic objectives2
Others
Basic objectives -Others
Isolate effective neutralizing antibodies to further develop effective agents and vaccine against HIV/AIDS.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Establishment of neutralizing monoclonal antibodies against HIV. Isolation of HIV from patients with recent infection.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with HIV-1 infection
Key exclusion criteria
1.Patients who have difficulty to donate additional blood because of some complications such as severe anemia
2.Patients under treatment of immune suppressive agents or anti-cancer agents.
3.Patients under treatment with interferon.
4.Patients who are determined not appropriate for the study by attending doctors.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuzo Matsushita |
Organization
Kumamoto University
Division name
Center for AIDS Research
Zip code
Address
2-2-1Honjyo Kumamoto, 860-0811, Japan
TEL
096-373-6536
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuzo Matsushita |
Organization
Kumamoto University
Division name
Center for AIDS Research
Zip code
Address
2-2-1Honjyo Kumamoto, 860-0811, Japan
TEL
096-373-6536
Homepage URL
shuzo@kumamoto-u.ac.jp
Sponsor or person
Institute
Matsushita project, Center for AIDS Research, Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Grant-in aid for scientific research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
AIDS Clinical Center (ACC),National Center for Global Health and Medicine (NCGM), Japan
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
熊本大学病院（熊本）、独立行政法人国立国際医療研究センター、エイズ治療・研究開発センター（東京）、国立病院機構九州医療センター（福岡）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 14 | 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
| 2010 | Year | 07 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 01 | Day |
Other
Other related information
Establishment and characterization of neutralizing monoclonal antibodies (nMAbs) from patients with HIV-infection. To analyze sensitivity to nMAbs and anti-viral agents recent clinical isolates will obtained from patients with HIV-infection.
Management information
Registered date
| 2010 | Year | 12 | Month | 14 | Day |
Last modified on
| 2010 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005497
