Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00164762
Status:
COMPLETED
Last Update Posted:
2007-10-01
First Post:
2005-09-12
Brief Title:
Nevirapine Resistance Study Nevirapine Resistance Among HIV-Infected Mothers
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Nevirapine Pharmacodynamics and Resistance Among HIV-Infected Mothers in Lilongwe Malawi
Status:
COMPLETED
Status Verified Date:
2007-09
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 is to determine whether the addition of zidovudine ZDV and lamivudine 3TC at the onset of labor and for up to seven days postpartum to single-dose nevirapine NVP is associated with a lower prevalence of NVP-resistant HIV compared to single-dose NVP without ZDV3TC
Detailed Description:
The primary purpose of the Nevirapine Resistance Study is to compare nevirapine NVP resistance of HIV at two and six weeks postpartum in women who are participating in two different programs currently ongoing in Lilongwe Malawi The first program is through the HIV Infection and Breastfeeding Interventions for Maternal and Infant Health also known as the Breastfeeding Antiretrovirals and Nutrition BAN Study a clinical trial where all enrolled women receive zidovudine ZDV and lamivudine 3TC at the onset of labor and for up to seven days postpartum in addition to single-dose nevirapine NVP The second program is the Call to Action CTA program sponsored by the Malawi Ministry of Health and Population MOHP and UNC Project The aim of the CTA program is to reduce mother to child transmission MTCT of HIV by providing women a single dose NVP to be taken at the onset of labor Study participants are tested for NVP-resistant HIV at two and six weeks postpartum and the prevalence of NVP-resistant virus is compared among the two groups receiving different peripartum anti-retroviral regimens
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 |
|---|---|---|---|
| SIP 26-04 | None | None | None |