Cord BloodNCT00342082
Effects of Anti-HIV Therapy on Red Blood Cells of HIV-infected Mothers and Their Infants
An observational study of Cord Blood, run by National Institute of Environmental Health Sciences (NIEHS) at 3 sites in United States.
Trial summary
This collaborative investigation between NIEHS, Duke University, and the University of North Carolina (UNC) will study red blood cells of babies born to HIV-infected women receiving anti-retroviral treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cord Blood
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Jun 2004to 28 Dec 2007
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HIV-infected
- Pregnant
- Treatment with antiretroviral regimen
- -Healthy Pregnant Female
Who cannot join
- -None
- -Delivery less than 32 weeks gestation
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27599-7030
Duke University Medical Center
Durham, North Carolina, 27710
NIEHS, Research Triangle Park
Research Triangle Park, North Carolina, 27709
About this study
Official title: A Pilot Study to Investigate Micronucleated Erythrocyte Frequencies in Infants Exposed to Nucleoside Antiretrovial Drugs in Utero and for 6 Weeks Postnatally
This collaborative investigation between NIEHS, Duke University, and the University of North Carolina (UNC) will study red blood cells of babies born to HIV-infected women receiving anti-retroviral treatment. Studies have shown that newborn mice whose mothers were given anti-HIV medications during pregnancy had abnormal red blood cells circulating in their blood stream, indicating genetic damage to the cells caused by the anti-HIV medications. It is not known if similar red blood cell abnormalities develop in human infants whose mothers received anti-HIV medication during their pregnancy. This study will examine red blood cells from infants exposed to anti-HIV medications and from non-exposed infants to look for differences between them involving this specific genetic damage.
Healthy pregnant women and HIV-infected pregnant women who received antiretroviral treatment during their last trimester of pregnancy and during labor may be eligible for this study. Babies of HIV-infected women are also included in the study. Candidates will be recruited from medical centers at Duke University and the UNC. HIV-infected mothers must plan to have their baby followed by either the UNC or the Duke Pediatric Infectious Disease clinic.
Read more
All women in the study will have 1 milliliter (less than 1/2 teaspoon) of blood collected for this study during delivery at the same time that other blood samples are obtained for their medical care. In addition, 5 ml (1 teaspoon) of umbilical cord blood will also be collected for this study at the time of delivery after the cord is no longer attached to the baby. This concludes participation of non-HIV infected women.
Babies born to HIV-infected mothers will have 1 ml of blood drawn between 0 to 3 days of life, between 4 to 6 weeks of life, and between 4 to 6 months of life. These bloodsamples will be collected at the same time as other routine scheduled blood draws.
Read the detailed description
This is an observational study of pregnant women and their newborns. The population will include 10 HIV infected women on any antiretroviral regimen and their newborn infants and 10 healthy women on no antiretroviral regimen and their newborn infants.
Primary Objective: To determine if micronucleated erythrocytes can be detected more frequently in cord blood of infants exposed to zidovudine in utero and intrapartum compared to cord blood from infants not exposed.
Secondary Objectives:
- To determine if micronucleated erythrocytes can be detected in pregnant women on any antiretrovial agents.
- To determine if micronucleated erythrocytes change in frequency in infants exposed to antiretrovial agents over the first 6 weeks of life, during the time the infant is exposed to Zidovudine.
- To determine the change in micronucleated erythrocytes in the infants after cessation or Zidovudine (6 months).
- Conditions
- Cord Blood
- Keywords
- Zidovudine, HIV, Cord Blood
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start25 Jun 2004
- Study completion28 Dec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cord BloodStudies 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
- Enrolment
- 0 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00342082
- Sponsor's protocol ID
- 999904242
- Other IDs
- 04-E-N242
- Status last verified
- 28 Dec 2007
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Connor EM, Sperling RS, Gelber R, Kiselev P, Scott G, O'Sullivan MJ, VanDyke R, Bey M, Shearer W, Jacobson RL, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med. 1994 Nov 3;331(18):1173-80. doi: 10.1056/NEJM199411033311801.
PubMed 7935654
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Investigate Micronucleated Erythrocyte Frequencies in Infants Exposed to Nucleoside Antiretrovial Drugs in Utero and for 6 Weeks Postnatally
- ClinicalTrials.gov ID
- NCT00342082
- Acronym / sponsor ID
- 999904242
- Conditions
- Cord Blood
- Keywords
- Zidovudine, HIV, Cord Blood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 0 participants
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 25 Jun 2004
- Study completion
- 28 Dec 2007
- First posted
- 21 Jun 2006 (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.
This collaborative investigation between NIEHS, Duke University, and the University of North Carolina (UNC) will study red blood cells of babies born to HIV-infected women receiving anti-retroviral treatment. Studies have shown that newborn mice whose mothers were given anti-HIV medications during pregnancy had abnormal red blood cells circulating in their blood stream, indicating genetic damage to the cells caused by the anti-HIV medications. It is not known if similar red blood cell abnormalities develop in human infants whose mothers received anti-HIV medication during their pregnancy. This study will examine red blood cells from infants exposed to anti-HIV medications and from non-exposed infants to look for differences between them involving this specific genetic damage.
Healthy pregnant women and HIV-infected pregnant women who received antiretroviral treatment during their last trimester of pregnancy and during labor may be eligible for this study. Babies of HIV-infected women are also included in the study. Candidates will be recruited from medical centers at Duke University and the UNC. HIV-infected mothers must plan to have their baby followed by either the UNC or the Duke Pediatric Infectious Disease clinic.
All women in the study will have 1 milliliter (less than 1/2 teaspoon) of blood collected for this study during delivery at the same time that other blood samples are obtained for their medical care. In addition, 5 ml (1 teaspoon) of umbilical cord blood will also be collected for this study at the time of delivery after the cord is no longer attached to the baby. This concludes participation of non-HIV infected women.
Babies born to HIV-infected mothers will have 1 ml of blood drawn between 0 to 3 days of life, between 4 to 6 weeks of life, and between 4 to 6 months of life. These bloodsamples will be collected at the same time as other routine scheduled blood draws.
Detailed description
This is an observational study of pregnant women and their newborns. The population will include 10 HIV infected women on any antiretroviral regimen and their newborn infants and 10 healthy women on no antiretroviral regimen and their newborn infants.
Primary Objective: To determine if micronucleated erythrocytes can be detected more frequently in cord blood of infants exposed to zidovudine in utero and intrapartum compared to cord blood from infants not exposed.
Secondary Objectives:
- To determine if micronucleated erythrocytes can be detected in pregnant women on any antiretrovial agents.
- To determine if micronucleated erythrocytes change in frequency in infants exposed to antiretrovial agents over the first 6 weeks of life, during the time the infant is exposed to Zidovudine.
- To determine the change in micronucleated erythrocytes in the infants after cessation or Zidovudine (6 months).
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- HIV-infected
- Pregnant
- Treatment with antiretroviral regimen
- -Healthy Pregnant Female
Key exclusion criteria (2 listed)
- -None
- -Delivery less than 32 weeks gestation
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
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 7935654Connor EM, Sperling RS, Gelber R, Kiselev P, Scott G, O'Sullivan MJ, VanDyke R, Bey M, Shearer W, Jacobson RL, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med. 1994 Nov 3;331(18):1173-80. doi: 10.1056/NEJM199411033311801.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cord Blood, run by National Institute of Environmental Health Sciences (NIEHS) at 3 sites in United States.
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 4 inclusion and 2 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00342082, which also lists 1 linked publication.
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 2 Jul 2017.