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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00007319 |
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.
Condition |
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HIV Infections HIV Seronegativity Atherosclerosis |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Carotid Artery Intima-Media Thickness in HIV-Infected and Uninfected Adults: A Pilot Study |
Estimated Enrollment: | 132 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria for Group 1
Inclusion Criteria for Group 2
Inclusion Criteria for Group 3
Exclusion Criteria for All Groups
United States, California | |
UCLA CARE Ctr | |
Los Angeles, California, United States, 90095 | |
Univ of Southern California / LA County USC Med Ctr | |
Los Angeles, California, United States, 900331079 | |
Kaiser Foundation Hosp | |
Harbor City, California, United States, 90710 | |
Harbor UCLA Med Ctr | |
Torrance, California, United States, 90502 | |
Kaiser Permanente LAMC | |
Los Angeles, California, United States, 90027 | |
Univ of California, San Diego | |
San Diego, California, United States, 92103 | |
United States, Hawaii | |
Univ of Hawaii | |
Honolulu, Hawaii, United States, 96816 | |
United States, Minnesota | |
Univ of Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
United States, Pennsylvania | |
Univ of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Washington | |
Univ of Washington | |
Seattle, Washington, United States, 98104 |
Study Chair: | Judith S. Currier, MD, MSc | UCLA CARE Center |
Study Chair: | Howard N. Hodis, MD | Atherosclerosis Research Unit, University of Southern California |
Study ID Numbers: | ACTG A5078, AACTG A5078 |
Study First Received: | December 16, 2000 |
Last Updated: | September 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00007319 |
Health Authority: | United States: Federal Government |
HIV Protease Inhibitors Risk Factors HIV Seronegativity Anti-HIV Agents |
Carotid Artery Tunica Intima Atherosclerosis |
Arterial Occlusive Diseases Virus Diseases Atherosclerosis Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Vascular Diseases Arteriosclerosis Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases |
Lentivirus Infections Cardiovascular Diseases Infection |