UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014809 |
|---|---|
| Receipt number | R000017218 |
| Scientific Title | Immune improvement by antiretroviral therapy in HIV-1 infected children |
| Date of disclosure of the study information | 2014/08/25 |
| Last modified on | 2017/08/11 09:48:53 |
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Basic information
Public title
Immune improvement by antiretroviral therapy in HIV-1 infected children
Acronym
Immune improvement by ART in HIV-infected children
Scientific Title
Immune improvement by antiretroviral therapy in HIV-1 infected children
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hiroshi ICHIMURA |
Organization
Graduate school of Medicine, Kanazawa University
Division name
Department of Viral infection and International Health
Zip code
Address
13-1, Takara-machi, Kanazawa-shi, Ishikawa, 920-8640, Japan
TEL
+81-76-265-2229
ichimura@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Xiuqiong Bi |
Organization
Graduate school of Medicine, Kanazawa University
Division name
Department of Viral infection and International Health
Zip code
Address
13-1, Takara-machi, Kanazawa-shi, Ishikawa, 920-8640, Japan
TEL
+81-76-265-2229
Homepage URL
bixiuqio@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Graduate school of Medicine, Kanazawa University
Institute
Department
Personal name
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)
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
| 2014 | Year | 08 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 08 | Month | 22 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017218
