Carotid Artery Thickness in HIV Infected & Uninfected NCT00007319

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT00007319
Other study ID #	ACTG A5078
Secondary ID	AACTG A5078
Status	Completed
Phase	N/A
First received	December 16, 2000
Last updated	September 16, 2008

Study information
Verified date	May 2006
Source	National Institute of Allergy and Infectious Diseases (NIAID)
Contact	n/a
Is FDA regulated	No
Health authority	United States: Federal Government
Study type	Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility
Status	Completed
Enrollment	132
Est. completion date
Est. primary completion date
Accepts healthy volunteers	Accepts Healthy Volunteers
Gender	Both
Age group	18 Years and older
Eligibility	Inclusion Criteria for Group 1 - 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 Inclusion Criteria for Group 2 - 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 Inclusion Criteria for Group 3 - HIV uninfected Exclusion Criteria for All Groups - 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country	Name	City	State
United States	Kaiser Foundation Hosp	Harbor City	California
United States	Univ of Hawaii	Honolulu	Hawaii
United States	Kaiser Permanente LAMC	Los Angeles	California
United States	UCLA CARE Ctr	Los Angeles	California
United States	Univ of Southern California / LA County USC Med Ctr	Los Angeles	California
United States	Univ of Minnesota	Minneapolis	Minnesota
United States	Univ of Pennsylvania	Philadelphia	Pennsylvania
United States	Univ of California, San Diego	San Diego	California
United States	Univ of Washington	Seattle	Washington
United States	Harbor UCLA Med Ctr	Torrance	California

Sponsors *(1)*
Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States,

References & Publications (6)

Barbaro G. HIV infection, highly active antiretroviral therapy and the cardiovascular system. Cardiovasc Res. 2003 Oct 15;60(1):87-95. Review. — View Citation

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. Review. — View Citation

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 inhib — View Citation

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. — View Citation

Penzak SR, Chuck SK. Management of protease inhibitor-associated hyperlipidemia. Am J Cardiovasc Drugs. 2002;2(2):91-106. Review. — View Citation

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. — View Citation

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Carotid Artery Thickness in HIV Infected and Uninfected Adults

Clinical Trial Details — Status: Completed

Administrative data

Study information