Maternal-fetal CD4 Microchimerism in HiV Exposed Newborns After Spontaneous Delivery and Cesarean Section
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|