[Release: NIAID to Evaluate Safety of Giving AZT to Pregnant Women] Page: 5 of 6
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five times a day) until delivery. During labor, they will again receive intravenous AZT until
the infant is born. Following delivery, AZT will not be continued; however, attempts will be
made to enroll study participants in other clinical trials in which they would have access to
AZT.
Throughout pregnancy, all participants will be carefully monitored, with weekly clinic
visits to assess the safety of AZT in both the mothers and their fetuses. Following delivery,
the infants will not receive AZT. They will be followed closely, receiving frequent physical
examinations and laboratory tests of blood and urine samples. After discharge from the
hospital, they will be examined at 1, 2, 4, 8 and 12 weeks, and routinely followed every 3
months for the first 18 months to assess growth and development, possible delayed drug
toxicity, and evidence of HIV infection or other complications. The children will receive
treatment for any infections or illnesses. Patients will be available for followup for at least
one year and preferably longer.
HIV infection in the women will be determined either by using the ELISA test to detect
HIV antibodies in the blood or by HIV viral culture. A positive ELISA result will be
confirmed by the Western blot test. The study participants, who must have no symptoms of
HIV infection, will receive counseling about the meaning of HIV infection and the potential
consequences to their offspring. In addition to the mother's consent, the father's consent
will be obtained if he is available. If he is unavailable, reasonable attempts will be made to
contact him.
The principal investigators of the study are M. J. O'Sullivan, M.D., and Wade Parks,
M.D., University of Miami, Florida; and Yvonne Bryson, M.D., and Pamela Boyer, M.D.,
University of California, Los Angeles, School of Medicine. Both universities are part of
NIAID's AIDS Clinical Trials Group, a nationwide network established to evaluate experimental
therapies for AIDS and HIV-related diseases. Burroughs Wellcome will provide the drug for
the study.
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National Institute of Allergy and Infectious Disease. [Release: NIAID to Evaluate Safety of Giving AZT to Pregnant Women], text, July 10, 1989; (https://texashistory.unt.edu/ark:/67531/metadc915767/m1/5/?rotate=270: accessed July 18, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Special Collections.