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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003095
Receipt No. R000003758
Scientific Title Evaluation of HLA-B*5701 screening prior to abacavir administration for prevention of the hypersensitivity reaction.
Date of disclosure of the study information 2010/02/01
Last modified on 2016/08/17

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Basic information
Public title Evaluation of HLA-B*5701 screening prior to abacavir administration for prevention of the hypersensitivity reaction.
Acronym HLA-B*5701 screening for prevention of abacavir hypersensitivity reaction.
Scientific Title Evaluation of HLA-B*5701 screening prior to abacavir administration for prevention of the hypersensitivity reaction.
Scientific Title:Acronym HLA-B*5701 screening for prevention of abacavir hypersensitivity reaction.
Region
Japan

Condition
Condition HIV infection
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Evaluation of HLA-B*5701 screening prior to abacavir administration for prevention of the hypersensitivity reaction.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Proportion of abacavir-hypersensitive patients to the HLA-B*5701-negative.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Gene
Interventions/Control_1 Abacavir is administered to HLA-B*5701-negative patients and the hypersensitivity will be judged in six weeks.
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 HIV-infected patients, irrespective of antiretroviral treatment experience, considered to initiate a regimen containing abacavir.
Key exclusion criteria Patients received abacavir once, or with severe hepatic dysfunction.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiaki Igarashi
Organization University of Fukui Hospital
Division name Department of Pharmacy
Zip code
Address 23-3, Matsuoka-Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan.
TEL 0776-61-3111(ext.3212)
Email igarashi@u-fukui.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiaki Igarashi
Organization University of Fukui Hospital
Division name Department of Pharmacy
Zip code
Address 23-3, Matsuoka-Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan.
TEL 0776-61-3111(ext.3212)
Homepage URL
Email igarashi@u-fukui.ac.jp

Sponsor
Institute Department of Pharmacy, University of Fukui Hospital
Institute
Department

Funding Source
Organization GlaxoSmithKline K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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 福井大学医学部附属病院(福井県)

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 01 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 Enrolling by invitation
Date of protocol fixation
2009 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2014 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 01 Month 26 Day
Last modified on
2016 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=R000003758

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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