Effects of Anti-HIV Therapy on Red Blood Cells of HIV-infected Mothers and Their Infants
Effects of Anti-HIV Therapy on Red Blood Cells of HIV-infected Mothers and Their Infants
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.
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).
-  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