HIV Infections Clinical Trial
Official title:
Carotid Artery Intima-Media Thickness in HIV-Infected and Uninfected Adults: A Pilot Study
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.
Determination of clinical, lipid, and non-lipid risk factors has been the traditional
approach for gauging an individual's 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 person's 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 patient's 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 waist/hip 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.
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