The study of the new regimen of the AZT administration to the neonate for preventing HIV mother-to-child transmission

The study of the new regimen of the AZT administration to the neonate for preventing HIV mother-to-child transmission - 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)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008935

Enrollment

Registered

2012-09-17

Start date

2012-09-03

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: The mother rejects the agreement for this study.

Design outcomes

Primary

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactMizue Tanaka

National Center for Global Health and Medicine pediatric

mitanaka@hosp.ncgm.go.jp03-3202-7181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026