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

This study is currently recruiting participants.
Verified October 2011 by Johann Wolfgang Goethe University Hospitals
Sponsor:
Information provided by (Responsible Party):
Dr. med. Horst Buxmann, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01450059
First received: October 7, 2011
Last updated: October 16, 2011
Last verified: October 2011
History of Changes
  Purpose

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
Human Immunodeficiency Virus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Maternal-fetal CD4 Microchimerism in HiV Exposed Newborns After Spontaneous Delivery and Cesarean Section

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 30
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)
Groups/Cohorts
Spontaneous delivery
Approximately 15 HiV exposed Newborns with low HiV transmission risk, born via spontaneous delivery.
Cesarean section
Approximately 15 HiV exposed Newborns with low HiV transmission risk, born via cesarean section.

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

Ages Eligible for Study:   up to 10 Minutes
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Approximately 30 HiV exposed newborns born via spontaneuous delivery or cesarean section.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01450059

Contacts
Contact: Horst Buxmann, Dr. med. 0049 69 6301 ext 5247 horst.buxmann@kgu.de
Contact: Rolf L Schloesser, Prof Dr med 0049 69 6301 ext 5120 rolf.schloesser@kgu.de

Locations
Germany
Clinic of the Johann Wolfgang-Goethe Univeristy Recruiting
Frankfurt/Main, Hesse, Germany, 60590
Contact: Horst Buxmann, Dr. med.     0049 69 6301 ext 5247     horst.buxmann@kgu.de    
Contact: Rolf L Schloesser, Prof Dr med     0049 69 6301 ext 5120     rolf.schloesser@kgu.de    
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.            
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
Principal Investigator: Horst Buxmann, Dr. med. Johann Wolfgang Goethe University Hospital Frankfurt/Main, Department of Neonatology
  More Information

Publications:

Responsible Party: Dr. med. Horst Buxmann, Principal Investigator, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01450059     History of Changes
Other Study ID Numbers: 31082011 FRA Mat Fet Chim
Study First Received: October 7, 2011
Last Updated: October 16, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Johann Wolfgang Goethe University Hospitals:
Human Immunodeficiency Virus
Microchimerism
Maternal-Fetal Exchange
Gestation
HiV-vertical transmission

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on March 14, 2013