Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00346567
Status:
COMPLETED
Last Update Posted:
2016-02-23
First Post:
2006-06-29
Brief Title:
Backup With Combivir or Single Dose SD Truvada in Order to Avoid Non-nucleoside Reverse Transcriptase Inhibitor NNRTI Resistance After SD Nevirapine for the Prevention of Mother-to-child Transmission PMTCT
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Clinical Trial Backup With Combivir AZT3TC or Single Dose sd Truvada FTCTDF in Order to Avoid NNRTI Resistance After sd Nevirapine for the Prevention of Mother-to-child Transmission MTCT
Status:
COMPLETED
Status Verified Date:
2009-02
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 aim of the study is to find short course alternatives to single dose sdnevirapine for the prevention of mother-to-child HIV-transmission with the same or better degree of transmission protection than sd nevirapine but with less NNRTI resistance development
Detailed Description:
Randomised open study comparing Zidovudine from 28 weeks gestation single dose Nevirapine 1 week of Combivir with Zidovudine from 28 weeks gestation single dose Nevirapine single dose of Truvada for the mothers during birth In both arms the infants will receive one dose of nevirapine within the first days after births as well as 7 to 28 days Zidovudine N 450 The study will be conducted at Ngamiani and Makorora Health Centres and Bombo Regional Hospital in Tanga Tanzania as a cooperation between Rigshospitalet Denmark University of Copenhagen and National Institute of Medical Research Tanzania
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