Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00197587
Status:
COMPLETED
Last Update Posted:
2013-05-20
First Post:
2005-09-12
Brief Title:
Prevention of Milk-Borne Transmission of HIV-1C in Botswana
Sponsor:
Harvard School of Public Health HSPH
Organization:
Harvard School of Public Health HSPH
Study Overview
Official Title:
Prevention of Milk-Borne Transmission of HIV-1C in Botswana Mashi
Status:
COMPLETED
Status Verified Date:
2013-05
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:
Mashi
Brief Summary:
The purpose of this study is to find the most effective and safe treatment to prevent the passage of HIV from an infected mother to her baby
Detailed Description:
1 To assess the effectiveness of the addition of a single dose of nevirapine NVP to Zidovudine ZDV also known as AZT as used in the Botswana mother-to-child transmission MTCT National Program in reducing transmission of HIV-1 from mother to child To determine if maternal NVP per HIVNET 012 protocol is necessary in the setting of maternal ZDV from 34 weeks gestation through delivery AND single-dose prophylactic infant NVP at birth plus ZDV from birth to 4 weeks for the reduction of transmission of HIV-1 from mother to child
2 To assess the effect of prophylactic AZT given to infants during breast feeding on HIV transmission
3 To confirm the safety and tolerance of one dose of NVP given to mothers and infants
4 To evaluate the safety and tolerance of AZT given to infants for up to 6 months of age
5 To determine the association between assigned infant feeding strategy and maternal morbidity and mortality
6 To determine the rates of virologic response to NNRTI-containing HAART at 26 and 52 weeks after initiating treatment among HIV women who previously received single dose NVP versus placebo during labour
2 To assess the effect of prophylactic AZT given to infants during breast feeding on HIV transmission
3 To confirm the safety and tolerance of one dose of NVP given to mothers and infants
4 To evaluate the safety and tolerance of AZT given to infants for up to 6 months of age
5 To determine the association between assigned infant feeding strategy and maternal morbidity and mortality
6 To determine the rates of virologic response to NNRTI-containing HAART at 26 and 52 weeks after initiating treatment among HIV women who previously received single dose NVP versus placebo during labour
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