Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00144261
Status:
COMPLETED
Last Update Posted:
2017-12-28
First Post:
2005-09-02
Brief Title:
An Open-label Non-randomized Single-arm Study to Investigate the Mechanisms by Which Nevirapine Increases Plasma HDL in HIV Subjects
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
An Open-label Non-randomized Single-arm Study to Investigate the Mechanisms by Which Nevirapine Increases Plasma High Density Lipoproteins Concentration in HIV Subjects Treated With VIRAMUNE Tablets
Status:
COMPLETED
Status Verified Date:
2017-12
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:
1 In order to obtain further insight as to how NVP affects HDL metabolism the in vivo kinetics of the HDL apolipoprotein Apo A-1 before and 6 weeks after initiation of NVP containing treatment were evaluated In addition the activity of the key enzymes related to HDL metabolism were assessed
Designated as safety issue No
2 In order to determine the relevance of the HDL increase in decreasing cardiovascular risk in HIV-positive subjects we evaluated endothelial function FMD as a surrogate marker for cardiovascular disease in patients
Designated as safety issue No
Designated as safety issue No
2 In order to determine the relevance of the HDL increase in decreasing cardiovascular risk in HIV-positive subjects we evaluated endothelial function FMD as a surrogate marker for cardiovascular disease in patients
Designated as safety issue No
Detailed Description:
None
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