Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398684
Status:
COMPLETED
Last Update Posted:
2008-05-07
First Post:
2006-11-13
Brief Title:
Nevirapine Plus Zidovudine to Prevent Perinatal HIV in Thailand
Sponsor:
Institut de Recherche pour le Developpement
Organization:
Institut de Recherche pour le Developpement
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-05
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:
The purpose of this study was to assess the efficacy of a single dose of the drug nevirapine NVP given to pregnant women at onset of labor and to their infant 48-72 hours after birth in addition to standard oral zidovudine ZDV or AZT prophylaxis for the prevention of mother-to-child transmission of HIV-1
Detailed Description:
Multicenter randomized three arms double-blind controlled study Study population was HIV-infected pregnant women who were on ZDV prophylaxis for more than two weeks and gave informed consent If eligible women completed a baseline check-up Women meeting selection criteria were randomly assigned to receive one of three study regimens in addition to ZDV prophylaxis
1 One dose maternal NVP treatment at onset of labor and one dose of infant NVP treatment 48-72 hours after birth
2 One dose maternal NVP treatment at onset of labor and one dose of infant placebo 48-72 hours after birth
3 One dose maternal placebo at onset of labor and one dose of infant placebo 48-72 hours after birth This was the reference study arm
Follow-up of women and infants was carried out on an outpatient basis except for delivery and the first three days after delivery
AMENDMENT
After the first interim analysis enrollment in Placebo-Placebo arm was terminated on May 2 2002 according to the recommendation of the Data and Safety Monitoring Board The target sample size was increased to 660 instead of 510 in each of the two remaining arms N-N and N-P to ensure enough power to test for non-inferiority between these arms with a limit of 25
1 One dose maternal NVP treatment at onset of labor and one dose of infant NVP treatment 48-72 hours after birth
2 One dose maternal NVP treatment at onset of labor and one dose of infant placebo 48-72 hours after birth
3 One dose maternal placebo at onset of labor and one dose of infant placebo 48-72 hours after birth This was the reference study arm
Follow-up of women and infants was carried out on an outpatient basis except for delivery and the first three days after delivery
AMENDMENT
After the first interim analysis enrollment in Placebo-Placebo arm was terminated on May 2 2002 according to the recommendation of the Data and Safety Monitoring Board The target sample size was increased to 660 instead of 510 in each of the two remaining arms N-N and N-P to ensure enough power to test for non-inferiority between these arms with a limit of 25
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None