Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050908
Status:
COMPLETED
Last Update Posted:
2013-07-29
First Post:
2002-12-30
Brief Title:
Blood Vessel Function in HIV-Infected Patients Taking Anti-HIV Drugs
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Endothelial Function in HIV-Infected Subjects Prior To and After Starting a Potent Antiretroviral Regimen
Status:
COMPLETED
Status Verified Date:
2013-07
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:
This is a substudy of ACTG A5142 The purpose of this substudy is to evaluate blood vessel function in HIV-infected patients taking anti-HIV drugs
Detailed Description:
Endothelial dysfunction assessed by measurement of brachial artery reactivity is associated with coronary artery disease Previous studies showed that patients taking HIV protease inhibitors PIs had a buildup of fatty deposits in their arteries and impaired flow-mediated vasodilation of the brachial artery whereas endothelial function was normal in HIV-infected individuals not taking PIs The effect of three different antiretroviral regimens on endothelial function in antiretroviral naïve HIV-infected patients will be examined in this substudy
Patients in this substudy will have Brachial Artery Reactivity Tests BARTs which are painless ultrasound tests of an artery in the lower arm Brachial artery reactivity will be measured at entry and at 4 and 24 weeks after patients are randomized to one of three open-label drug regimens in ACTG A5142 Brachial artery reactivity in response to two vasoactive stimuli flow-mediated and nitroglycerin will be assessed by measuring brachial artery diameter and flow velocity Blood will be drawn at Weeks 4 and 24 for insulin and lipid tests Patients will fast and refrain from tobacco and caffeine use for at least 8 hours prior to each study visit For the duration of the substudy patients will be asked not to change the amount of fruits juices antioxidants and tea that they consume
Patients in this substudy will have Brachial Artery Reactivity Tests BARTs which are painless ultrasound tests of an artery in the lower arm Brachial artery reactivity will be measured at entry and at 4 and 24 weeks after patients are randomized to one of three open-label drug regimens in ACTG A5142 Brachial artery reactivity in response to two vasoactive stimuli flow-mediated and nitroglycerin will be assessed by measuring brachial artery diameter and flow velocity Blood will be drawn at Weeks 4 and 24 for insulin and lipid tests Patients will fast and refrain from tobacco and caffeine use for at least 8 hours prior to each study visit For the duration of the substudy patients will be asked not to change the amount of fruits juices antioxidants and tea that they consume
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 |
|---|---|---|---|
| 10812 | REGISTRY | DAIDS ES | None |
| ACTG A5152s | None | None | None |