UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027282 |
|---|---|
| Receipt number | R000031258 |
| Scientific Title | The real-world duration of the initial regimen of anti-retroviral therapy in HIV patients in Japan: an observational database analysis |
| Date of disclosure of the study information | 2017/05/31 |
| Last modified on | 2017/05/09 14:46:10 |
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Basic information
Public title
The real-world duration of the initial regimen of anti-retroviral therapy in HIV patients in Japan: an observational database analysis
Acronym
ART duration study
Scientific Title
The real-world duration of the initial regimen of anti-retroviral therapy in HIV patients in Japan: an observational database analysis
Scientific Title:Acronym
ART duration study
Region
| Japan |
Condition
Condition
HIV infection
Classification by specialty
| Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the treatment duration of initial ART regimens classified according to the key drug class
Basic objectives2
Others
Basic objectives -Others
To examine the treatment duration of each key drug class-based initial ART regimen stratified by type of backbone
To describe the characteristics of patients who experienced a key drug switch in each key drug class-based initial ART regimen
To analyze the common switching strategies by describing each key drug class switch
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The duration of initial ART regimens by key drug class.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with a disease record of HIV (ICD-10 code: B20-B24)
Patients with a prescription records of antiretroviral drugs during April 2008 and December 2016
Patients at age 18 years or older in the month of the begging of the initial ART
Key exclusion criteria
Patients with a disease record of HIV-2 infection (Japanese Disease Name Code: 8847288).
Target sample size
1700
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryuta Sakuma |
Organization
MSD K.K.
Division name
Medical Affairs
Zip code
Address
1-13-12 Kudan-kita, Chiyoda-ku, Tokyo 102-8667, Japan
TEL
03-6272-2043
ryuta.sakuma@merck.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryuta Sakuma |
Organization
MSD K.K.
Division name
Medical Affairs
Zip code
Address
1-13-12 Kudan-kita, Chiyoda-ku, Tokyo 102-8667, Japan
TEL
03-6272-2043
Homepage URL
ldgproject@merck.com
Sponsor or person
Institute
MSD K.K.
Institute
Department
Personal name
Funding Source
Organization
MSD K.K.
Organization
Division
Category of Funding Organization
Self funding
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
| 2017 | Year | 05 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 04 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective database analysis
Non-intervention, observational study
No patient will be newly enrolled.
Management information
Registered date
| 2017 | Year | 05 | Month | 09 | Day |
Last modified on
| 2017 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031258
