Carotid Artery Thickness in HIV Infected and Uninfected Adults

NCT00007319 | Completed

• 2 other identifiers: ACTG A5078AACTG A5078
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 10

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.

Conditions

HIV Infections; HIV Seronegativity; Atherosclerosis

Keywords

HIV Protease Inhibitors; Risk Factors; HIV Seronegativity; Anti-HIV Agents; Carotid Artery; Tunica Intima; Atherosclerosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV infected
• 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

You may not qualify if:

• Diabetes or current use of oral medications for diabetes
• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (10)

Kaiser Foundation Hosp

Harbor City, California, 90710, United States

Location

Kaiser Permanente LAMC

Los Angeles, California, 90027, United States

Location

Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, 900331079, United States

Location

UCLA CARE Ctr

Los Angeles, California, 90095, United States

Location

Univ of California, San Diego

San Diego, California, 92103, United States

Location

Harbor UCLA Med Ctr

Torrance, California, 90502, United States

Location

Univ of Hawaii

Honolulu, Hawaii, 96816, United States

Location

Univ of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Univ of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Univ of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (6)

• 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.

  PMID: 14522410 BACKGROUND

• 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.

  PMID: 12927947 BACKGROUND

• 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.

  PMID: 14600519 BACKGROUND

• 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.

  PMID: 14727985 BACKGROUND

• 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.

  PMID: 14691419 BACKGROUND

• 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.

  PMID: 15905673 RESULT

MeSH Terms

Conditions

HIV Infections; Atherosclerosis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Judith S. Currier, MD, MSc

  University of California, Los Angeles

  STUDY CHAIR

• Howard N. Hodis, MD

  Atherosclerosis Research Unit, University of Southern California

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: December 16, 2000
• First Posted: August 31, 2001
• Last Updated: September 17, 2008

Record last verified: 2006-05

Locations

US (10)