UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001102 |
|---|---|
| Receipt number | 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 11:12:34 |
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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
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
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001334
