Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00007319
Status:
COMPLETED
Last Update Posted:
2008-09-17
First Post:
2000-12-16
Brief Title:
Carotid Artery Thickness in HIV Infected and Uninfected Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Carotid Artery Intima-Media Thickness in HIV-Infected and Uninfected Adults A Pilot Study
Status:
COMPLETED
Status Verified Date:
2006-05
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:
None
Brief Summary:
The intima-media thickness IMT test is a low cost non-invasive way to measure the thickness of the carotid artery the large artery in the neck The purpose of this study is to compare the thickness of the carotid artery among HIV infected adults taking protease inhibitors PIs HIV infected adults not taking PIs and HIV uninfected adults and to examine how the thickness may change over time
Detailed Description:
Determination of clinical lipid and non-lipid risk factors has been the traditional approach for gauging an individuals risk for coronary artery disease CAD However the IMT test which uses sound waves to measure the thickness of the carotid artery has been found to diagnose CAD and predict a persons risk for heart disease as well as or better than lipid and non-lipid risk factors This study will use the IMT test to see if anti-HIV treatment and HIV infection affect a patients risk of developing atherosclerosis hardening of the arteries by comparing carotid artery thickness among HIV infected adults taking PIs HIV infected adults not taking PIs and HIV uninfected adults
There are 3 groups in this study Group 1 will comprise HIV infected participants currently taking a PI-containing regimen Group 2 will comprise HIV infected participants who are not taking PIs Group 3 will comprise HIV uninfected participants At each site participants will be enrolled by triads consisting of an individual from each group Each member of the triad will be closely matched by gender age smoking and menopausal status race and normal or hypertensive blood pressure All 3 members of the triad must be identified before participants are registered to the study
All participants will visit the clinic at Weeks 1 24 48 72 96 and 144 3 years At each visit participants will have a physical exam medical history and waisthip ratio assessment blood collection and an IMT test The absolute value for carotid IMT will be compared among the 3 groups Viral load and CD4 counts will also be measured in Group 1 and 2 participants
There are 3 groups in this study Group 1 will comprise HIV infected participants currently taking a PI-containing regimen Group 2 will comprise HIV infected participants who are not taking PIs Group 3 will comprise HIV uninfected participants At each site participants will be enrolled by triads consisting of an individual from each group Each member of the triad will be closely matched by gender age smoking and menopausal status race and normal or hypertensive blood pressure All 3 members of the triad must be identified before participants are registered to the study
All participants will visit the clinic at Weeks 1 24 48 72 96 and 144 3 years At each visit participants will have a physical exam medical history and waisthip ratio assessment blood collection and an IMT test The absolute value for carotid IMT will be compared among the 3 groups Viral load and CD4 counts will also be measured in Group 1 and 2 participants
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 |
|---|---|---|---|
| AACTG A5078 | None | None | None |