Maternal-fetal CD4 Microchimerism in HiV Exposed Newborns After Spontaneous Delivery and Cesarean Section
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.
Human Immunodeficiency Virus
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Maternal-fetal CD4 Microchimerism in HiV Exposed Newborns After Spontaneous Delivery and Cesarean Section|
- Maternal CD4+ t-cells in HiV exposed Newborns [ Time Frame: Six weeks after date of birth ] [ Designated as safety issue: Yes ]The maternal CD4+ t-cells are measured by microchimersimanalysis
- HiV transmission rate [ Time Frame: 6 month after birth ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]HiV-PCR analysis from maternal CD4+ cells
- Measurement of maternal CD8+ t-cells in the Newborn [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Measurement of maternal CD8+ t-cells by microchimerismanalysis
Biospecimen Retention: Samples With DNA
Umbilical Cord blood Blood from peripheral vene
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01450059
|Contact: Horst Buxmann, Dr. med.||0049 69 6301 ext firstname.lastname@example.org|
|Contact: Rolf L Schloesser, Prof Dr med||0049 69 6301 ext email@example.com|
|Clinic of the Johann Wolfgang-Goethe Univeristy||Recruiting|
|Frankfurt/Main, Hesse, Germany, 60590|
|Contact: Horst Buxmann, Dr. med. 0049 69 6301 ext 5247 firstname.lastname@example.org|
|Contact: Rolf L Schloesser, Prof Dr med 0049 69 6301 ext 5120 email@example.com|
|Principal Investigator: Horst Buxmann, Dr. med.|
|Sub-Investigator: Anke Reitter, Dr. med.|
|Sub-Investigator: Christopher Koenigs, Dr. med.|
|Sub-Investigator: Sascha Bapistella, Cand. med.|
|Sub-Investigator: Martin Stuermer, PD. Dr. med.|
|Sub-Investigator: Peter Bader, Prof Dr med|
|Sub-Investigator: Rolf L Schloesser, Prof Dr med|
|Sub-Investigator: Richard Linde, Dr. Dr. med.|
|Sub-Investigator: Hanns Ackermann, Dr rer med|
|Sub-Investigator: Andre Willasch, Dr. med.|
|Principal Investigator:||Horst Buxmann, Dr. med.||Johann Wolfgang Goethe University Hospital Frankfurt/Main, Department of Neonatology|