Maternal-fetal CD4 Microchimerism in HiV Exposed Newborns After Spontaneous Delivery and Cesarean Section
|ClinicalTrials.gov Identifier: NCT01450059|
Recruitment Status : Completed
First Posted : October 12, 2011
Last Update Posted : February 22, 2016
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.
|Condition or disease|
|Human Immunodeficiency Virus|
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.
|Study Type :||Observational|
|Actual Enrollment :||54 participants|
|Official Title:||Maternal-fetal CD4 Microchimerism in HiV Exposed Newborns After Spontaneous Delivery and Cesarean Section|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||August 2015|
Approximately 15 HiV exposed Newborns with low HiV transmission risk, born via spontaneous delivery.
Approximately 15 HiV exposed Newborns with low HiV transmission risk, born via cesarean section.
- 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
- HiV transmission rate [ Time Frame: 6 month after birth ]Measurement of HiV PCR at the age of 6 month after birth
- Analysis of HiV in maternal CD4+ t-cells [ Time Frame: 2 month after delivery ]HiV-PCR analysis from maternal CD4+ cells
- Measurement of maternal CD8+ t-cells in the Newborn [ Time Frame: 6 weeks ]Measurement of maternal CD8+ t-cells by microchimerismanalysis
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01450059
|Clinic of the Johann Wolfgang-Goethe Univeristy|
|Frankfurt/Main, Hesse, Germany, 60590|
|Principal Investigator:||Horst Buxmann, Dr. med.||Johann Wolfgang Goethe University Hospital Frankfurt/Main, Department of Neonatology|