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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000008935
Receipt No. 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 2021/03/25

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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
Email 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
Email mitanaka@hosp.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

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
Email 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 Enrolling by invitation
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
2021 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010473

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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