Carotid Artery Thickness in HIV Infected and Uninfected Adults
NCT ID: NCT00007319
Last Updated: 2008-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
132 participants
OBSERVATIONAL
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Have taken at least 1 PI continuously for 2 or more years and are currently taking at least 1 PI. Stopping therapy for 4 weeks or less for management of side effects or to change therapy is allowed.
* Viral load of 10,000 copies/ml or less
* HIV infected
* Not currently receiving PIs or have not taken PIs in at least 3 months
* Not planning to initiate PI therapy in the few months following study entry
* Viral load of 10,000 copies/ml or less
* If not currently on anti-HIV treatment, must have been on treatment for at least 6 months in the past
* HIV uninfected
Exclusion Criteria
* Kidney disease
* ALT or AST greater than 2.5 times the upper limit of normal
* Hypothyroidism
* Family history (parents, brothers, sisters, or children) of heart attacks before age 55 in males and age 65 in females
* Alcohol or drug abuse
* Pregnant or plan to become pregnant during the study
* Body mass index (BMI) greater than 30
* Systemic chemotherapy or radiation therapy
* Systemic steroids (prednisone or equivalent) at doses greater than 5 mg/day for more than 30 consecutive days
* History of coronary heart disease or stroke (including chest pain, heart attack, or abnormal stress test)
* Uncontrolled hypertension
18 Years
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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Judith S. Currier, MD, MSc
Role: STUDY_CHAIR
University of California, Los Angeles
Howard N. Hodis, MD
Role: STUDY_CHAIR
Atherosclerosis Research Unit, University of Southern California
Locations
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Kaiser Foundation Hosp
Harbor City, California, United States
Kaiser Permanente LAMC
Los Angeles, California, United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States
UCLA CARE Ctr
Los Angeles, California, United States
Univ of California, San Diego
San Diego, California, United States
Harbor UCLA Med Ctr
Torrance, California, United States
Univ of Hawaii
Honolulu, Hawaii, United States
Univ of Minnesota
Minneapolis, Minnesota, United States
Univ of Pennsylvania
Philadelphia, Pennsylvania, United States
Univ of Washington
Seattle, Washington, United States
Countries
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References
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Barbaro G. HIV infection, highly active antiretroviral therapy and the cardiovascular system. Cardiovasc Res. 2003 Oct 15;60(1):87-95. doi: 10.1016/s0008-6363(02)00828-3.
Calza L, Manfredi R, Chiodo F. Hyperlipidaemia in patients with HIV-1 infection receiving highly active antiretroviral therapy: epidemiology, pathogenesis, clinical course and management. Int J Antimicrob Agents. 2003 Aug;22(2):89-99. doi: 10.1016/s0924-8579(03)00115-8.
Mary-Krause M, Cotte L, Simon A, Partisani M, Costagliola D; Clinical Epidemiology Group from the French Hospital Database. Increased risk of myocardial infarction with duration of protease inhibitor therapy in HIV-infected men. AIDS. 2003 Nov 21;17(17):2479-86. doi: 10.1097/00002030-200311210-00010.
Penzak SR, Chuck SK. Management of protease inhibitor-associated hyperlipidemia. Am J Cardiovasc Drugs. 2002;2(2):91-106. doi: 10.2165/00129784-200202020-00003.
Varriale P, Saravi G, Hernandez E, Carbon F. Acute myocardial infarction in patients infected with human immunodeficiency virus. Am Heart J. 2004 Jan;147(1):55-9. doi: 10.1016/j.ahj.2003.07.007.
Currier JS, Kendall MA, Zackin R, Henry WK, Alston-Smith B, Torriani FJ, Schouten J, Mickelberg K, Li Y, Hodis HN; AACTG 5078 Study Team. Carotid artery intima-media thickness and HIV infection: traditional risk factors overshadow impact of protease inhibitor exposure. AIDS. 2005 Jun 10;19(9):927-33. doi: 10.1097/01.aids.0000171406.53737.f9.
Other Identifiers
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AACTG A5078
Identifier Type: -
Identifier Source: secondary_id
ACTG A5078
Identifier Type: -
Identifier Source: org_study_id