Human Immunodeficiency VirusNCT01450059
Maternal-fetal CD4 Microchimerism in HiV Exposed Newborns After Spontaneous Delivery and Cesarean Section
An observational study of Human Immunodeficiency Virus, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 1 minute to 10 minutes
- Conditions the study is for
- Human Immunodeficiency Virus
- How many people
- 54 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2011to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 10 minutes
- All sexes
- No healthy volunteers
- Child
Study population: Approximately 30 HiV exposed newborns born via spontaneuous delivery or cesarean section.
Who may be able to join
- HiV exposed Newborns with normal risk of HiV transmission.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinic of the Johann Wolfgang-Goethe Univeristy
Frankfurt am Main, Hesse, 60590
About this study
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.
Read the 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.
- Conditions
- Human Immunodeficiency Virus
- Keywords
- Human Immunodeficiency Virus, Microchimerism, Maternal-Fetal Exchange, Gestation, HiV-vertical transmission
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal CD4+ t-cells in HiV exposed Newborns
The maternal CD4+ t-cells are measured by microchimersimanalysis
Measured: Six weeks after date of birth
Secondary outcomes (3)
HiV transmission rate
Measurement of HiV PCR at the age of 6 month after birth
Measured: 6 month after birth
Analysis of HiV in maternal CD4+ t-cells
HiV-PCR analysis from maternal CD4+ cells
Measured: 2 month after delivery
Measurement of maternal CD8+ t-cells in the Newborn
Measurement of maternal CD8+ t-cells by microchimerismanalysis
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startAug 2011
- Primary completionApr 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Horst Buxmann, Johann Wolfgang Goethe University Hospital
- Investigators
- Horst Buxmann, Dr. med., Principal investigator, Johann Wolfgang Goethe University Hospital Frankfurt/Main, Department of Neonatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450059
- Sponsor's protocol ID
- 31082011 FRA Mat Fet Chim
- Status last verified
- Feb 2016
- First submitted
- 7 Oct 2011
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20059573Gemeinsame 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.
PubMed 19172555Willasch 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.
PubMed 17984038
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal-fetal CD4 Microchimerism in HiV Exposed Newborns After Spontaneous Delivery and Cesarean Section
- ClinicalTrials.gov ID
- NCT01450059
- Acronym / sponsor ID
- 31082011 FRA Mat Fet Chim
- Conditions
- Human Immunodeficiency Virus
- Keywords
- Human Immunodeficiency Virus, Microchimerism, Maternal-Fetal Exchange, Gestation, HiV-vertical transmission
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 12 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 minute to 10 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Approximately 30 HiV exposed newborns born via spontaneuous delivery or cesarean section.
Key inclusion criteria (1 listed)
- HiV exposed Newborns with normal risk of HiV transmission.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maternal CD4+ t-cells in HiV exposed Newborns
Time frame: Six weeks after date of birth
The maternal CD4+ t-cells are measured by microchimersimanalysis
3 secondary outcomes
HiV transmission rate
Time frame: 6 month after birth
Analysis of HiV in maternal CD4+ t-cells
Time frame: 2 month after delivery
Measurement of maternal CD8+ t-cells in the Newborn
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
- Background: PubMed 20059573European 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.
- Background: PubMed 19172555Gemeinsame 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.
- Background: PubMed 17984038Willasch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Horst Buxmann, Dr. med. principal investigator
Johann Wolfgang Goethe University Hospital Frankfurt/Main, Department of Neonatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal CD4+ t-cells in HiV exposed Newborns (time frame: Six weeks after date of birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01450059, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2016.