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

Human Immunodeficiency Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01450059
• Other study ID #: 31082011 FRA Mat Fet Chim
• Status: Completed
• Phase: N/A
• First received: October 7, 2011
• Last updated: February 19, 2016
• Start date: August 2011
• Est. completion date: August 2015

Study information

• Verified date: February 2016
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 10 Minutes

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Locations

Country	Name	City	State
Germany	Clinic of the Johann Wolfgang-Goethe Univeristy	Frankfurt/Main	Hesse

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View Citation

Gemeinsame Erklärung* 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 für Kinderheilkunde und Jugendmedizin (DGKJ); Pädiatrischen Arbeitsgemeinschaft AIDS Deutschland (PAAD); Deutschen Gesellschaft für Gynäkologie und Geburtshilfe (DGGG); Nationalen Referenzzentrums für 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. Review. German. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal CD4+ t-cells in HiV exposed Newborns	The maternal CD4+ t-cells are measured by microchimersimanalysis	Six weeks after date of birth	Yes
Secondary	HiV transmission rate	Measurement of HiV PCR at the age of 6 month after birth	6 month after birth	Yes
Secondary	Analysis of HiV in maternal CD4+ t-cells	HiV-PCR analysis from maternal CD4+ cells	2 month after delivery	Yes
Secondary	Measurement of maternal CD8+ t-cells in the Newborn	Measurement of maternal CD8+ t-cells by microchimerismanalysis	6 weeks	No