Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000751
Status:
COMPLETED
Last Update Posted:
2008-09-30
First Post:
1999-11-02
Brief Title:
A Phase III Randomized Double-Blind Controlled Study of the Use of Anti-HIV Immune Serum Globulin HIVIG for the Prevention of Maternal-Fetal HIV Transmission in Pregnant Women and Newborns Receiving Zidovudine AZT
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Randomized Double-Blind Controlled Study of the Use of Anti-HIV Immune Serum Globulin HIVIG for the Prevention of Maternal-Fetal HIV Transmission in Pregnant Women and Newborns Receiving Zidovudine AZT
Status:
COMPLETED
Status Verified Date:
2006-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: