Effects of Anti-HIV Therapy on Red Blood Cells of HIV-Infected Mothers and Their Infants

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00342082
First received: June 19, 2006
Last updated: March 5, 2008
Last verified: December 2007
  Purpose

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.


Condition
Cord Blood

Study Type: Observational
Official Title: A Pilot Study to Investigate Micronucleated Erythrocyte Frequencies in Infants Exposed to Nucleoside Antiretrovial Drugs in Utero and for 6 Weeks Postnatally

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 0
Study Start Date: June 2004
Estimated Study Completion Date: December 2007
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).
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA: (Treated Group)
  • HIV-infected
  • Pregnant
  • Treatment with antiretroviral regimen

INCLUSION CRITERIA: (Control Group)

-Healthy Pregnant Female

EXCLUSION CRITERIA: (Treated Group)

-None

EXCLUSION CRITERIA: (Control Group)

-Delivery less than 32 weeks gestation

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00342082

Locations
United States, North Carolina
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States, 27599-7030
Duke University Medical Center
Durham, North Carolina, United States, 27710
NIEHS, Research Triangle Park
Research Triangle Park, North Carolina, United States, 27709
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00342082     History of Changes
Other Study ID Numbers: 999904242, 04-E-N242
Study First Received: June 19, 2006
Last Updated: March 5, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Zidovudine
HIV
Cord Blood

ClinicalTrials.gov processed this record on April 15, 2014