Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061321
Status:
COMPLETED
Last Update Posted:
2008-07-31
First Post:
2003-05-23
Brief Title:
Daily Nevirapine to Prevent Mother to Infant Transmission of HIV
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Prevention of Maternal to Infant HIV Transmission in India
Status:
COMPLETED
Status Verified Date:
2007-08
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:
SWEN
Brief Summary:
Infants who are breast-fed by HIV infected mothers have an increased risk of becoming infected with HIV Standard therapy for the prevention of HIV infections in infants included zidovudine ZDV prior to the onset of labor a single dose of nevirapine NVP for women during labor and a single dose of NVP for newborns given 72 hours after birth This study will determine if giving low dose daily NVP to breastfed infants of HIV infected mothers in addition to standard therapy will be more effective than standard therapy alone at preventing HIV infections in these infants
Detailed Description:
This study will evaluate the safety and effectiveness of adding daily infant NVP to standard prevention measures to decrease vertical transmission of HIV
According to current statistics from the study site approximately 70 of the pregnant HIV infected women in this study will have begun antenatal ZDV prior to the initiation of NVP at labor The remaining 30 of the HIV infected women enrolled in this trial will have been previously undiagnosed These women will be diagnosed with HIV infection either at the time they present to the delivery room in stage 1 of labor or immediately postpartum if they present for delivery late in labor and cannot provide informed consent for HIV screening prior to delivery
All infants will receive the standard does of NVP at 72 hours postpartum Infants will then be randomized to receive either daily NVP and a daily multivitamin MVI or a daily MVI alone Infants will take NVPMVI or MVI alone during Weeks 2 to 6 postpartum The primary outcome measure is infant HIV infection rates at 6 months
Two additional related cohorts of women will be followed for comparison 1 an equal number of HIV uninfected women and their children will be enrolled for comparison of postpartum morbidity and mortality and 2 consenting HIV infected women and their children who choose not to enroll in the clinical trial or are ineligible because they are not breastfeeding will be enrolled in an ancillary cohort
According to current statistics from the study site approximately 70 of the pregnant HIV infected women in this study will have begun antenatal ZDV prior to the initiation of NVP at labor The remaining 30 of the HIV infected women enrolled in this trial will have been previously undiagnosed These women will be diagnosed with HIV infection either at the time they present to the delivery room in stage 1 of labor or immediately postpartum if they present for delivery late in labor and cannot provide informed consent for HIV screening prior to delivery
All infants will receive the standard does of NVP at 72 hours postpartum Infants will then be randomized to receive either daily NVP and a daily multivitamin MVI or a daily MVI alone Infants will take NVPMVI or MVI alone during Weeks 2 to 6 postpartum The primary outcome measure is infant HIV infection rates at 6 months
Two additional related cohorts of women will be followed for comparison 1 an equal number of HIV uninfected women and their children will be enrolled for comparison of postpartum morbidity and mortality and 2 consenting HIV infected women and their children who choose not to enroll in the clinical trial or are ineligible because they are not breastfeeding will be enrolled in an ancillary cohort
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