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Clinical Trials/NCT01450059
NCT01450059
Completed
Not Applicable

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

Johann Wolfgang Goethe University Hospital1 site in 1 country54 target enrollmentAugust 2011
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ConditionsHuman Immunodeficiency Virus

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Human Immunodeficiency Virus
Sponsor
Johann Wolfgang Goethe University Hospital
Enrollment
54
Locations
1
Primary Endpoint
Maternal CD4+ t-cells in HiV exposed Newborns
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
August 2015
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Johann Wolfgang Goethe University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr. med. Horst Buxmann

Principal Investigator

Johann Wolfgang Goethe University Hospital

Eligibility Criteria

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
  • •Major congenital defects
  • •Chromosomal anomalies

Outcomes

Primary Outcomes

Maternal CD4+ t-cells in HiV exposed Newborns

Time Frame: Six weeks after date of birth

The maternal CD4+ t-cells are measured by microchimersimanalysis

Secondary Outcomes

  • HiV transmission rate(6 month after birth)
  • Analysis of HiV in maternal CD4+ t-cells(2 month after delivery)
  • Measurement of maternal CD8+ t-cells in the Newborn(6 weeks)

Study Sites (1)

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