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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004720
Receipt No. 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

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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
Email

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
Email shuzo@kumamoto-u.ac.jp

Sponsor
Institute Matsushita project, Center for AIDS Research, Kumamoto University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005497

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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