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

NCT00342082 | Completed

• 2 other identifiers: 99990424204-E-N242
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Cord Blood

Keywords

Zidovudine; HIV; Cord Blood

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-infected
• Pregnant
• Treatment with antiretroviral regimen
• Healthy Pregnant Female

You may not qualify if:

• None
• Delivery less than 32 weeks gestation

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (3)

University of North Carolina Hospitals

Chapel Hill, North Carolina, 27599-7030, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

NIEHS, Research Triangle Park

Research Triangle Park, North Carolina, 27709, United States

Location

Related Publications (1)

• 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.

  PMID: 7935654 BACKGROUND

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: June 25, 2004
• Study Completion: December 28, 2007
• Last Updated: July 2, 2017

Record last verified: 2007-12-28

Locations

US (3)