UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015270
Receipt number R000017688
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 2014/09/27
Last modified on 2014/09/27 13:35:47

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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 for 6 weeks(previous regimen) and AZT for 4 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 for 6 weeks(previous regimen) and AZT for 4 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 administration for 4 weeks,in the neonates who are born from HIV positive mothers

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1)HIV mother-to-child transmission:
HIV antibody detection at one and half year of age
2)The degree of born marrow suppression:The minimum values of hemoglobin,white blood cells,neutrophile counts,platelets at 0 to 1 day of age and 2 to 4 months of age

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


Dynamic allocation


Institution consideration


Blocking


Concealment



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 4 weeks orally/intravenously

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

0 years-old <=

Age-upper limit

0 years-old >=

Gender

Male and Female

Key inclusion criteria

1)The neonates who are born by HIV positive mothers in National Center for Global Health and Medicine(NCGM)
2)The neonates whose informed consent is obtained from HIV positive mothers

Key exclusion criteria

The neonates whose informed consent is not obtained from HIV positive mothers

Target sample size

12


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mizue Tanaka

Organization

National Center for Global Health and Medicine

Division name

Department of Pediatrics

Zip code


Address

1-21-1,Toyama,Shinjuku-ku,Tokyo,Japan

TEL

03-3202-7181

Email

mitanaka@hosp.ncgm.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mizue Tanaka

Organization

National Center for Global Health and Medicine

Division name

Department of Pediatrics

Zip code


Address

1-21-1,Toyama,Shinjuku-ku,Tokyo,Japan

TEL

03-3202-7181

Homepage URL


Email

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


Address


Tel


Email



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 09 Month 27 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 09 Month 27 Day

Date of IRB


Anticipated trial start date

2014 Year 09 Month 27 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 09 Month 27 Day

Last modified on

2014 Year 09 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017688


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name