Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000960
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Zidovudine in HIV-Infected Pregnant Women and Their Infants
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Randomized Placebo-Controlled Trial to Evaluate the Efficacy Safety and Tolerance of Oral Zidovudine AZT in Pregnant HIV Infected Women and Their Infants
Status:
COMPLETED
Status Verified Date:
2021-10
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 determine whether the rate of HIV transmission from mother to infant can be reduced by continuous oral zidovudine AZT treatment to HIV infected pregnant women intravenous AZT during childbirth and oral AZT treatment of the newborn infant from birth to six weeks of age The study is also designed to evaluate the safety of AZT for both the pregnant woman and the newborn infant
No method exists to prevent transmission of HIV from an infected mother to her newborn infant Giving an antiviral agent such as AZT to the mother and to the newborn could in theory decrease the risk of infection to the newborn by reducing the exposure of the fetus to maternal virus or by preventive treatment of the fetus before exposure
No method exists to prevent transmission of HIV from an infected mother to her newborn infant Giving an antiviral agent such as AZT to the mother and to the newborn could in theory decrease the risk of infection to the newborn by reducing the exposure of the fetus to maternal virus or by preventive treatment of the fetus before exposure
Detailed Description:
No method exists to prevent transmission of HIV from an infected mother to her newborn infant Giving an antiviral agent such as AZT to the mother and to the newborn could in theory decrease the risk of infection to the newborn by reducing the exposure of the fetus to maternal virus or by preventive treatment of the fetus before exposure
Patients are enrolled during their pregnancy between 14 and 34 weeks of gestation They are chosen by random selection to receive AZT or placebo Treatment continues until labor at which time they begin to receive continuous intravenous study drug Study drug treatment is discontinued after the umbilical cord is clamped AZT is then offered all women as per labeled indications for 6 weeks postpartum while appropriate medical followup is being arranged Mothers who develop an AIDS defining illness or whose CD4 cell counts decrease to less than 200 cellsmm3 during pregnancy are offered open-label drug at that time The mother is followed by her primary obstetrician at an AIDS Clinical Trials Unit ACTU or subunit facility The mother may deliver at the ACTU or a non-ACTU site Treatment of the infant is started in the newborn nursery and continues on an outpatient basis Infants receive the same study treatment as the mother for 6 weeks and are monitored to week 78
Patients are enrolled during their pregnancy between 14 and 34 weeks of gestation They are chosen by random selection to receive AZT or placebo Treatment continues until labor at which time they begin to receive continuous intravenous study drug Study drug treatment is discontinued after the umbilical cord is clamped AZT is then offered all women as per labeled indications for 6 weeks postpartum while appropriate medical followup is being arranged Mothers who develop an AIDS defining illness or whose CD4 cell counts decrease to less than 200 cellsmm3 during pregnancy are offered open-label drug at that time The mother is followed by her primary obstetrician at an AIDS Clinical Trials Unit ACTU or subunit facility The mother may deliver at the ACTU or a non-ACTU site Treatment of the infant is started in the newborn nursery and continues on an outpatient basis Infants receive the same study treatment as the mother for 6 weeks and are monitored to week 78
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11050 | REGISTRY | DAIDS ES Registry Number | None |