Clinical trial NCT01450059: Maternal-fetal CD4 Microchimerism in HiV Exposed Newborns After Spontaneous Delivery and Cesarean Section
Official title: Maternal-fetal CD4 Microchimerism in HiV Exposed Newborns After Spontaneous Delivery and Cesarean Section
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus
Keywords: Human Immunodeficiency Virus
Microchimerism
Maternal-Fetal Exchange
Gestation
HiV-vertical transmission
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2011-10-12
Enrollment: 54
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 30 HiV exposed newborns born via spontaneuous delivery or cesarean section.

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.

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
* Outborns
* Asphyxia
* Major congenital defects
* Chromosomal anomalies

Primary outcomes:
measure: Maternal CD4+ t-cells in HiV exposed Newborns
timeFrame: Six weeks after date of birth
Secondary outcomes:
measure: HiV transmission rate
timeFrame: 6 month after birth
measure: Analysis of HiV in maternal CD4+ t-cells
timeFrame: 2 month after delivery
measure: Measurement of maternal CD8+ t-cells in the Newborn
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Frankfurt/Main
country: Germany
facility: Clinic of the Johann Wolfgang-Goethe Univeristy
state: Hesse
Study officials:
affiliation: Johann Wolfgang Goethe University Hospital Frankfurt/Main, Department of Neonatology
name: Horst Buxmann, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: European Collaborative Study; Boer K, England K, Godfried MH, Thorne C. Mode of delivery in HIV-infected pregnant women and prevention of mother-to-child transmission: changing practices in Western Europe. HIV Med. 2010 Jul 1;11(6):368-78. doi: 10.1111/j.1468-1293.2009.00800.x. Epub 2010 Jan 4.
citation: Gemeinsame Erklarung* der Deutschen AIDS-Gesellschaft (DAIG); Osterreichischen AIDS-Gesellschaft (OAG); Kompetenznetzes HIV/AIDS sowie des Robert-Koch-Institutes Berlin (RKI); Deutschen Arbeitsgemeinschaft niederniedergelassener Arzte in der Versorgung von HIV-und AIDS-Patienten (DAGNA); Deutschen Gesellschaft fur Kinderheilkunde und Jugendmedizin (DGKJ); Padiatrischen Arbeitsgemeinschaft AIDS Deutschland (PAAD); Deutschen Gesellschaft fur Gynakologie und Geburtshilfe (DGGG); Nationalen Referenzzentrums fur Retroviren (NRZ) der Deutschen AIDS-Hilfe (DAH). [German-Austrian recommendations for HIV treatment during pregnancy and for newborns exposed to HIV--Update 2008]. Dtsch Med Wochenschr. 2009 Jan;134 Suppl 1:S40-54. doi: 10.1055/s-0028-1123974. Epub 2009 Jan 26. No abstract available. German.
citation: Willasch A, Schneider G, Reincke BS, Shayegi N, Kreyenberg H, Kuci S, Weber G, Van Der Reijden B, Niethammer D, Klingebiel T, Bader P. Sequence polymorphism systems for quantitative real-time polymerase chain reaction to characterize hematopoietic chimerism-high informativity and sensitivity as well as excellent reproducibility and precision of measurement. Lab Hematol. 2007;13(3):73-84. doi: 10.1532/LH96.07004.