Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000808
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers
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 the bioavailability pharmacokinetics and short-term safety and tolerance of nevirapine in HIV-1 infected pregnant women and their newborns when nevirapine is given to the mother during active labor and when their neonates are dosed during the first week of life To determine the short-term safety profile of mothers receiving zidovudine AZT who received nevirapine during active labor and their neonates who received no dose a single dose or multiple doses of nevirapine and who are receiving AZT during the first 6 weeks of life
Treatment of HIV-1 infected pregnant women during active labor may result in therapeutic levels of nevirapine in the neonate at the time of exposure to HIV-1 during parturition decreasing the neonates risk of infection
Treatment of HIV-1 infected pregnant women during active labor may result in therapeutic levels of nevirapine in the neonate at the time of exposure to HIV-1 during parturition decreasing the neonates risk of infection
Detailed Description:
Treatment of HIV-1 infected pregnant women during active labor may result in therapeutic levels of nevirapine in the neonate at the time of exposure to HIV-1 during parturition decreasing the neonates risk of infection
Pregnant women in active labor receive single doses of oral nevirapine The neonates of the first 4-6 PER AMENDMENT 82796 was 4 mothers receive no drug while the neonates of the second 4-6 PER AMENDMENT 82796 was 4 patient cohort receive a single dose of nevirapine If neonatal antiviral levels of nevirapine are not sustained for 7 days after the single dose a third cohort of 4-6 PER AMENDMENT 82796 was 4 pregnant women will receive a single dose of nevirapine and their neonates will receive multiple doses of nevirapine to maintain an antiviral effect for 7 days
Pregnant women in active labor receive single doses of oral nevirapine The neonates of the first 4-6 PER AMENDMENT 82796 was 4 mothers receive no drug while the neonates of the second 4-6 PER AMENDMENT 82796 was 4 patient cohort receive a single dose of nevirapine If neonatal antiviral levels of nevirapine are not sustained for 7 days after the single dose a third cohort of 4-6 PER AMENDMENT 82796 was 4 pregnant women will receive a single dose of nevirapine and their neonates will receive multiple doses of nevirapine to maintain an antiviral effect for 7 days
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 |
|---|---|---|---|
| 11227 | REGISTRY | DAIDS ES Registry Number | None |