UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The real-world duration of the initial regimen of anti-retroviral therapy in HIV patients in Japan: an observational database analysis
Title of the study (Brief title)	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	Ryuta Sakuma
Organization	MSD K.K.
Division name	Medical Affairs
Address	1-13-12 Kudan-kita, Chiyoda-ku, Tokyo 102-8667, Japan
TEL	03-6272-2043
Email	ryuta.sakuma@merck.com

Public contact
Name of contact person	Ryuta Sakuma
Organization	MSD K.K.
Division name	Medical Affairs
Address	1-13-12 Kudan-kita, Chiyoda-ku, Tokyo 102-8667, Japan
TEL	03-6272-2043
Homepage URL
Email	ldgproject@merck.com

Sponsor
Institute	MSD K.K.
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 04 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031258