To evaluate the effect of anti-HIV immune serum globulin (HIVIG) versus immune globulin (IVIG) administered during pregnancy and to the newborn, in combination with zidovudine (AZT) administered intrapartum and to the newborn, on incidence of HIV infection in infants born to HIV-infected women who received AZT during pregnancy for medical indications. Vertical transmission of HIV from mother to child may occur before, during, or after parturition (via breast-feeding). It is believed that therapy administered both during pregnancy and intrapartum may help prevent vertical transmission. Additionally, adjunctive short-term antiretroviral therapy for the newborn, following the intensive viral exposure presumed to occur at birth, may be necessary.
Vertical transmission of HIV from mother to child may occur before, during, or after parturition (via breast-feeding). It is believed that therapy administered both during pregnancy and intrapartum may help prevent vertical transmission. Additionally, adjunctive short-term antiretroviral therapy for the newborn, following the intensive viral exposure presumed to occur at birth, may be necessary. Pregnant women who are currently receiving AZT are randomized at 20-30 weeks of gestation to begin receiving either HIVIG or IVIG every 28 days up to delivery. Within 12 hours after birth, the infant receives an infusion of matching study drug. During labor, all women receive an intravenous loading dose of AZT administered over 1 hour, followed by continuous infusion during the intrapartum period until the umbilical cord is clamped. All infants receive AZT syrup every 6 hours, beginning as soon as oral fluids are tolerated but within 8-12 hours after birth and continuing for 6 weeks. Women are followed until 26 weeks postpartum. Infants are followed at weeks 1, 2, 4, and then every 4 weeks through week 24, every 12 weeks through week 60, at week 78 (18 months), and at week 104 (24 months).
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
1,600
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, United States
UCLA Med Ctr / Pediatric
Los Angeles, California, United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, United States
San Francisco Gen Hosp
San Francisco, California, United States
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UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States
Denver Gen Hosp
Denver, Colorado, United States
Children's Hosp of Denver
Denver, Colorado, United States
Univ of Connecticut / Farmington
Farmington, Connecticut, United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, United States
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