UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006133 |
|---|---|
| Receipt number | R000007254 |
| Scientific Title | An exploratory study on the establishment and evaluation of individualized HAART |
| Date of disclosure of the study information | 2011/08/10 |
| Last modified on | 2021/09/01 14:39:52 |
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Basic information
Public title
An exploratory study on the establishment and evaluation of individualized HAART
Acronym
Keio-HAART study
Scientific Title
An exploratory study on the establishment and evaluation of individualized HAART
Scientific Title:Acronym
Keio-HAART study
Region
| Japan |
Condition
Condition
HIV
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate individualized HAART
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. HIV tropism
2. relationship between HIV tropism and patient backgrounds
A Patient backgrounds(age,sex,date of diagnosis, HIV-RNA, CD4 counts at diagnosis, lowest CD4 counts, treatment history, regimen/dose/treatment term, drugs, AIDS history)
B drug concentrations in blood
C drug concentrations in hair and saliva
D HIV-RNA in saliva
E drug susceptibility
F HIV-RNA and CD4 counts at the time of HIV tropism testing
G metabolic marker such as bone density at the time of HIV tropism testing
Key secondary outcomes
Time course of above factors
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 patients
20 years or older
Written informed consent obtained from the subject.
Key exclusion criteria
Patients during pregnancy or lactation
Patients who we consider inappropriate
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Hasegawa |
Organization
Keio University School of Medicine
Division name
Centor for Infectious Disease and Infection Control
Zip code
Address
Shinanomachi 35 Shinjyuku-ku Tokyo
TEL
03-3353-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Hasegawa |
Organization
Keio University School of Medicine
Division name
Centor for Infectious Disease and Infection Control
Zip code
Address
Shinanomachi 35 Shinjyuku-ku Tokyo
TEL
03-3353-1211
Homepage URL
Sponsor or person
Institute
Keio University School of Medicine Centor for Infectious Disease and Infection Control
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine Centor for Infectious Disease and Infection Control
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Negishi Clinic
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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 10 | 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
| 2011 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective case-control sampling
Analyze the association between phenotypes and biomarkers (HIV tropism,CD4 counts,HIV-RNA,drug concentrations,drug susceptibility)
Management information
Registered date
| 2011 | Year | 08 | Month | 09 | Day |
Last modified on
| 2021 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007254
