UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study regarding screening tests for HIV complications associated with aging in HIV infected patients.
Title of the study (Brief title)	The study of HIV complications and PET
Region	Japan

Condition
Condition	HIV infection
Classification by specialty	Infectious disease
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To find out the possibility of early detection of malignant tumors and dementia associated with aging in HIV infected patients through performing FDG-PET/CT examinations and ancillary tests (e.g. upper gastrointestinal endoscopy, chest CT, tumor marker test, head MRI, neuropsychological test, etc.).
Basic objectives2	Others
Basic objectives -Others	Epidemiology
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Presence of undiagnosed malignant tumor and/or dementia in HIV positive patients with hemophilia.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Starting November 2016 to end of March 2019, we will conduct two malignant tumor screening tests, including FDG-PET/ CT examination, chest CT examination, upper gastrointestinal endoscopy, blood tumor marker test, stool test, urine test and blood chemistry study with an interval of more than one year in between tests. As a screening test for dementia, we will conduct head MRI, neuropsychological test, and FDG-PET/CT examination (also serves as a malignant tumor screening test) once.
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	35 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	1) HIV infected patients with hemophilia who are 35 years old or older 2) A consent to participate has been obtained in a written form.
Key exclusion criteria	1) If an attending physician decides the patient requires urgent treatment 2) A patient with poor control of diabetes (FBS>150mg/dL) 3) A patient with serious underlying disease, which may lead to liver/kidney dysfunction and/or metabolic disorder 4) A patient with mental illness or psychiatric symptoms determined to confront difficulty when participating in the study 5) A patient with history of hypersensitivity to FDG 6) Other patients, whose attending physician has determined inappropriate to participate
Target sample size	50

Research contact person
Name of lead principal investigator	Shinichi Oka
Organization	National Center for Global Health and Medicine
Division name	AIDS Clinical Center
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL	03-3202-7181
Email	oka@acc.ncgm.go.jp

Public contact
Name of contact person	Shinichi Oka
Organization	National Center for Global Health and Medicine
Division name	AIDS Clinical Center
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL	03-3202-7181
Homepage URL
Email	oka@acc.ncgm.go.jp

Sponsor
Institute	AIDS Clinical Center, National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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	国立国際医療研究センター（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 20 Day
Anticipated trial start date	2016 Year 11 Month 15 Day
Last follow-up date	2019 Year 02 Month 20 Day
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

Management information
Registered date	2016 Year 11 Month 07 Day
Last modified on	2019 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028461