NCT01450059

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

February 22, 2016

Status Verified

February 1, 2016

Enrollment Period

2.7 years

First QC Date

October 7, 2011

Last Update Submit

February 19, 2016

Conditions

Human Immunodeficiency Virus

Keywords

Human Immunodeficiency VirusMicrochimerismMaternal-Fetal ExchangeGestationHiV-vertical transmission

Outcome Measures

Primary Outcomes (1)

  • Maternal CD4+ t-cells in HiV exposed Newborns

    The maternal CD4+ t-cells are measured by microchimersimanalysis

    Six weeks after date of birth

Secondary Outcomes (3)

  • HiV transmission rate

    6 month after birth

  • Analysis of HiV in maternal CD4+ t-cells

    2 month after delivery

  • Measurement of maternal CD8+ t-cells in the Newborn

    6 weeks

Study Arms (2)

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.

Eligibility Criteria

Age1 Minute - 10 Minutes
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • HiV exposed Newborns with normal risk of HiV transmission.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic of the Johann Wolfgang-Goethe Univeristy

Frankfurt am Main, Hesse, 60590, Germany

Location

Related 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.

    PMID: 20059573BACKGROUND

  • 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.

    PMID: 19172555BACKGROUND

  • 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.

    PMID: 17984038BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Umbilical Cord blood Blood from peripheral vene

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Horst Buxmann, Dr. med.

    Johann Wolfgang Goethe University Hospital Frankfurt/Main, Department of Neonatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 7, 2011

First Posted

October 12, 2011

Study Start

August 1, 2011

Primary Completion

April 1, 2014

Study Completion

August 1, 2015

Last Updated

February 22, 2016

Record last verified: 2016-02

Locations

DE(1)