UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Immune improvement by antiretroviral therapy in HIV-1 infected children
Title of the study (Brief title)	Immune improvement by ART in HIV-infected children
Region	Asia(except Japan)

Condition
Condition	Human immunodeficiency virus type 1 (HIV-1) infection
Classification by specialty	Infectious disease Pediatrics
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	(1) To find appropriate immunological markers for monitoring anti-retroviral therapy (ART) effects and prognosis of HIV/AIDS (acquired immune deficiency syndrome). (2) To figure out the genetic factors (single nucleotide polymorphisms, SNPs) related to the therapeutic outcomes and/or the side effects of ART.
Basic objectives2	Others
Basic objectives -Others	Immunology
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Activation and differentiation of CD4+ and CD8+ cells and the proportion of different CD4+ cell subsets such as Th1/Th2/Th17/Treg (regulatory T cells), proportion of MAIT cells
Key secondary outcomes	(1) HIV-1 viral load (VL) (2) CD4+ cell count (3) SNPs related to therapeutic outcomes of ART (4) Concentration of sCD14

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) HIV(+) ART(-): children who will start ART for the first time in their life. (2) HIV(-): HIV-negative children whose age and gender matched with subject (1)
Key exclusion criteria	The children whose consent is not obtained
Target sample size	100

Research contact person
Name of lead principal investigator	Hiroshi ICHIMURA
Organization	Graduate school of Medicine, Kanazawa University
Division name	Department of Viral infection and International Health
Address	13-1, Takara-machi, Kanazawa-shi, Ishikawa, 920-8640, Japan
TEL	+81-76-265-2229
Email	ichimura@med.kanazawa-u.ac.jp

Public contact
Name of contact person	Xiuqiong Bi
Organization	Graduate school of Medicine, Kanazawa University
Division name	Department of Viral infection and International Health
Address	13-1, Takara-machi, Kanazawa-shi, Ishikawa, 920-8640, Japan
TEL	+81-76-265-2229
Homepage URL
Email	bixiuqio@staff.kanazawa-u.ac.jp

Sponsor
Institute	Graduate school of Medicine, Kanazawa University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	National Hospital of Pediatrics, Hanoi, Vietnam
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	2014 Year 08 Month 25 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 08 Month 22 Day
Anticipated trial start date	2014 Year 08 Month 25 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	This is a prospective study. HIV-infected children will be followed up and their immune situation will be analyzed before ART and 6,12,18,24 months after ART start. HIV-negative children will be analyzed only for one time as control.

Management information
Registered date	2014 Year 08 Month 09 Day
Last modified on	2017 Year 08 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017218