Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074412
Status:
COMPLETED
Last Update Posted:
2023-02-16
First Post:
2003-12-11
Brief Title:
Using Nevirapine to Prevent Mother-to-Child HIV Transmission During Breastfeeding
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 Trial to Determine the Efficacy and Safety of an Extended Regimen of Nevirapine in Infants Born to HIV-Infected Women to Prevent Vertical HIV Transmission During Breastfeeding
Status:
COMPLETED
Status Verified Date:
2023-01
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 many benefits of breastfeeding are well documented However because of the risk of mother-to-child transmission MTCT of HIV from an HIV infected mother to her infant there is considerable concern over the practice especially in developing countries The purpose of this study is to determine the safety and effectiveness of the anti-HIV drug nevirapine NVP in preventing MTCT of HIV in breastfeeding infants born to HIV infected women in South Africa Tanzania Uganda and Zimbabwe
Detailed Description:
Breastfeeding provides general health growth and development benefits to an infant and significantly decreases the risk of certain acute and chronic diseases Breastfeeding also decreases financial burden on the mother by decreasing the need for infant formula and health care for the infant However clinical evidence has shown that HIV can be readily transmitted through breast milk although the risk of HIV MTCT over time while breastfeeding has been difficult to determine Given the many advantages of breastfeeding and the significant obstacles to substituting formula for breast milk in developing countries there is an urgent need to make breastfeeding by HIV infected women safe This study will evaluate the safety and efficacy of an extended NVP regimen for prevention of MTCT of HIV through breastfeeding
This study will last approximately 35 years Motherinfant pairs will be enrolled over a period of 18 to 24 months During the third trimester of pregnancy HIV infected participants will receive HIV counseling and the intrapartumneonatal two-dose NVP prophylaxis regimen to prevent MTCT Mothers will also be given infant feeding options counseling and information on administering the study drug to the infant Infants who were randomly assigned to receive a placebo and older than 6 weeks of age as of 081007 OR to receive NVP will continue their treatment assignment Infants who were randomly assigned to receive a placebo and are 6 weeks of age or less as of 081007 will receive open-label NVP through Day 42 of life For all other participants all randomized infants will receive extended NVP through 6 weeks Day 42 of life All eligible infants will be randomly assigned to one of two groups at Week 6 following birth The first group will receive extended NVP treatment the second group will receive nevirapine placebo Randomized infants will receive the extended NVP or NVP placebo through the first 6 months of life or until cessation of breastfeeding whichever occurs earlier Mothers will be instructed to begin giving their infants their assigned intervention starting at Day 3 to Day 7 postpartum All mothers and infants outside of the study will be offered the local standard of care antiretroviral ARV regimen for the prevention of MTCT but these ARVs will not be provided by the study
Follow-up evaluations will be conducted at Weeks 2 and 6 and Months 3 6 12 and 18 for mothers and at Weeks 2 5 6 and 8 and Months 3 4 5 6 9 12 and 18 for infants Study visits will include physical examinations blood tests including HIV tests and medical histories Study participants will be followed for up to 35 years
This study will last approximately 35 years Motherinfant pairs will be enrolled over a period of 18 to 24 months During the third trimester of pregnancy HIV infected participants will receive HIV counseling and the intrapartumneonatal two-dose NVP prophylaxis regimen to prevent MTCT Mothers will also be given infant feeding options counseling and information on administering the study drug to the infant Infants who were randomly assigned to receive a placebo and older than 6 weeks of age as of 081007 OR to receive NVP will continue their treatment assignment Infants who were randomly assigned to receive a placebo and are 6 weeks of age or less as of 081007 will receive open-label NVP through Day 42 of life For all other participants all randomized infants will receive extended NVP through 6 weeks Day 42 of life All eligible infants will be randomly assigned to one of two groups at Week 6 following birth The first group will receive extended NVP treatment the second group will receive nevirapine placebo Randomized infants will receive the extended NVP or NVP placebo through the first 6 months of life or until cessation of breastfeeding whichever occurs earlier Mothers will be instructed to begin giving their infants their assigned intervention starting at Day 3 to Day 7 postpartum All mothers and infants outside of the study will be offered the local standard of care antiretroviral ARV regimen for the prevention of MTCT but these ARVs will not be provided by the study
Follow-up evaluations will be conducted at Weeks 2 and 6 and Months 3 6 12 and 18 for mothers and at Weeks 2 5 6 and 8 and Months 3 4 5 6 9 12 and 18 for infants Study visits will include physical examinations blood tests including HIV tests and medical histories Study participants will be followed for up to 35 years
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 |
|---|---|---|---|
| 10142 | REGISTRY | DAIDS ES | None |