Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074399
Status:
COMPLETED
Last Update Posted:
2009-08-07
First Post:
2003-12-11
Brief Title:
Nevirapine NVP Use to Prevent Mother-to-Child 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:
Nevirapine NVP Use to Prevent Maternal-Infant HIV Transmission A Randomized Clinical Trial of Two Doses of NVP Compared to Six Weeks of NVP for the Prevention of Maternal-Infant HIV Transmission in the Breastfeeding Infant
Status:
COMPLETED
Status Verified Date:
2009-08
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:
None
Brief Summary:
HIV can be transmitted from an HIV infected mother to her infant through her breast milk The purpose of this study is to determine whether giving infants of HIV infected mothers the anti-HIV drug nevirapine NVP for six weeks will reduce the risk of HIV transmission
Study hypothesis Six weeks of nevirapine prophylaxis provided to the infant will decrease HIV transmission through breastfeeding
Study hypothesis Six weeks of nevirapine prophylaxis provided to the infant will decrease HIV transmission through breastfeeding
Detailed Description:
The use of antiretroviral therapy during late pregnancy intrapartum and immediately postpartum prevents a high proportion of vertical transmission Potential means of decreasing HIV transmission through breastfeeding along with the risks and benefits of early weaning need to be further evaluated The potential impact of early weaning interventions on the breastfeeding habits of the HIV uninfected population needs to be considered as well This study seeks to identify a way to make breastfeeding safe for HIV infected women who choose to breastfeed
A single dose of NVP given to infants of HIV infected mothers appears to provide some protection against vertical transmission NVPs long half-life allows simple dosing making it more feasible and affordable to implement in a developing country This study will determine whether extending the NVP dosing to six weeks will significantly decrease transmission during the first several months of breastfeeding
A single dose of NVP given to infants of HIV infected mothers appears to provide some protection against vertical transmission NVPs long half-life allows simple dosing making it more feasible and affordable to implement in a developing country This study will determine whether extending the NVP dosing to six weeks will significantly decrease transmission during the first several months of breastfeeding
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIGAT Project | None | None | None |