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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001102
Receipt No. R000001334
Scientific Title Pharmacokinetic study of rifabutin in HIV-1-positive Japanese individuals
Date of disclosure of the study information 2008/03/28
Last modified on 2013/02/07

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Basic information
Public title Pharmacokinetic study of rifabutin in HIV-1-positive Japanese individuals
Acronym Rifabutin PK study
Scientific Title Pharmacokinetic study of rifabutin in HIV-1-positive Japanese individuals
Scientific Title:Acronym Rifabutin PK study
Region
Japan

Condition
Condition Mycobacteriosis in HIV-positive individuals
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the pharmacodkinetics of rifabutin in HIV-infected Japanese individuals with or without antiretroviral therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pharmacokinetic parameters: Cmax, Tmax, AUC, t1/2.
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

Not applicable
Gender Male and Female
Key inclusion criteria HIV-positive individuals who require anti-Mycobacterial therapy including rifabutin and are obtained informed concents.
Key exclusion criteria Those who have recieved rifabutine within previous 28 days before study enrollment or who are suspected to have allergy for rifabutin.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junko Tanuma
Organization National Center for Global Health and Medicine
Division name AIDS Clinical Center
Zip code
Address 1-21-1 Toyama, Shinjuku, Tokyo, Japan
TEL 03-3202-7181
Email

Public contact
Name of contact person
1st name
Middle name
Last name Junko Tanuma
Organization International Medical Center of Japan
Division name AIDS Clinical Center
Zip code
Address
TEL 03-3202-7181
Homepage URL
Email

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2008 Year 03 Month 28 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
2008 Year 02 Month 08 Day
Date of IRB
Anticipated trial start date
2008 Year 02 Month 01 Day
Last follow-up date
2010 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The rifabutin concentration in plasma is measured at 0, 0.5, 1, 2, 4, 6, 8, 12, and 24hr after dosing in day 1, 7 and 30.

Management information
Registered date
2008 Year 03 Month 28 Day
Last modified on
2013 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001334

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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