UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008935 |
|---|---|
| Receipt number | R000010473 |
| Scientific Title | The study of the new regimen of the AZT administration to the neonate for preventing HIV mother-to-child transmission |
| Date of disclosure of the study information | 2012/09/17 |
| Last modified on | 2023/03/27 14:24:14 |
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Basic information
Public title
The study of the new regimen of the AZT administration to the neonate for preventing HIV mother-to-child transmission
Acronym
Comparative analysis of the effectiveness and safety between two regimens; AZT 2mg/kg four times a day for 6 weeks (previous regimen) and AZT 4mg/kg twice a day for 6 weeks (new regimen)
Scientific Title
The study of the new regimen of the AZT administration to the neonate for preventing HIV mother-to-child transmission
Scientific Title:Acronym
Comparative analysis of the effectiveness and safety between two regimens; AZT 2mg/kg four times a day for 6 weeks (previous regimen) and AZT 4mg/kg twice a day for 6 weeks (new regimen)
Region
| Japan |
Condition
Condition
HIV
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the effectiveness and safety in the new regimen, AZT 4mg/kg twice a day for 6 weeks, in the neonate who was born from HIV-positive mother.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)HIV transmission at 1 year and 6 month: HIV antibody detection
2)The degree of born marrow suppression: The minimum number of hemoglobin, white blood cell, neutrophile count, platelet between initial AZT administration and 1 or 2 months after completion.
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
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The neonates are given 4mg/kg of AZT twice a day for 6 weeks orally/intravenously
Extension criteria
The neonates who receive HIV or suspected HIV infection
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
| 1 | days-old | <= |
Age-upper limit
| 30 | days-old | > |
Gender
Male and Female
Key inclusion criteria
1)The neonates who are born by HIV positive mother in National Center for Global Health and Medicine (NCGM)
2)The agreement was obtained from the HIV positive mother after verbal explanation of the purposes of the study.
Key exclusion criteria
The mother rejects the agreement for this study.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Mizue |
| Middle name | |
| Last name | Tanaka |
Organization
National Center for
Global Health and Medicine
Division name
pediatric
Zip code
1628655
Address
1-21-1 Toyama,Shinjuku-ku,Tokyo162-8655 JAPAN
TEL
03-3202-7181
mitanaka@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Mizue |
| Middle name | |
| Last name | Tanaka |
Organization
National Center for Global Health and Medicine
Division name
pediatric
Zip code
1628655
Address
1-21-1 Toyama,Shinjuku-ku,Tokyo162-8655 JAPAN
TEL
03-3202-7181
Homepage URL
mitanaka@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Global Health and Medicine
Address
1-21-1 Toyama,Shinjuku-ku,Tokyo162-8655 JAPAN
Tel
03-3202-7181
rinrijm@hosp.ncgm.go.jp
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
| 2012 | Year | 09 | Month | 17 | 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
Completed
Date of protocol fixation
| 2012 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2012 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 17 | Day |
Last modified on
| 2023 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010473
