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Maternal-fetal CD4 Microchimerism in HiV Exposed Newborns After Spontaneous Delivery and Cesarean Section

Completed
Conditions
Human Immunodeficiency Virus
Registration Number
NCT01450059
Lead Sponsor
Johann Wolfgang Goethe University Hospital
Brief Summary

The aim of this single centre study is to measure maternal CD4+ t-cells in HiV exposed Newborns after spontaneous birth in comparison to cesarean section.

This may have an influence on the risk of vertical HiV transmission.

Detailed Description

At birth maternal CD4+ t-cells from umbilical cord blood and placenta blood are measured by microchimerism-analysis.

After 6 weeks the maternal CD4+ t-cells are measured in the blood of the babies blood.

Additionally we look for HiV in maternal CD4+ t-cells.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
54
Inclusion Criteria

• HiV exposed Newborns with normal risk of HiV transmission.

Exclusion Criteria
  • HiV exposed Newborns wiht elevated or high risk of HiV transmission.
  • HiV exposed Newborns of mothers not full of age.
  • missing informed consent of at least the mother
  • Outborns
  • Asphyxia
  • Major congenital defects
  • Chromosomal anomalies

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Maternal CD4+ t-cells in HiV exposed NewbornsSix weeks after date of birth

The maternal CD4+ t-cells are measured by microchimersimanalysis

Secondary Outcome Measures
NameTimeMethod
HiV transmission rate6 month after birth

Measurement of HiV PCR at the age of 6 month after birth

Analysis of HiV in maternal CD4+ t-cells2 month after delivery

HiV-PCR analysis from maternal CD4+ cells

Measurement of maternal CD8+ t-cells in the Newborn6 weeks

Measurement of maternal CD8+ t-cells by microchimerismanalysis

Trial Locations

Locations (1)

Clinic of the Johann Wolfgang-Goethe Univeristy

🇩🇪

Frankfurt/Main, Hesse, Germany

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