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AzTrials

HIV InfectionsNCT00455793

Subclinical Atherosclerosis in HIV-infected Patients

An observational study of HIV Infections and Coronary Atherosclerosis, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

We will obtain data using multi-slice CT technology to detect subclinical coronary disease in the HIV population. Determination of subclinical cardiovascular disease using noninvasive technology and elucidation of the associated risk factors will help to guide targeted therapy to prevent cardiovascular events in this… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections, Coronary Atherosclerosis
How many people
263 participants
Where
1 siteUnited States
Study dates
Jun 2006to Feb 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: HIV infected men and women and non-HIV infected control men and women

Who may be able to join

  • Men and women age 18-60
  • BMI 20-35
  • Previously documented HIV disease for 5 years or longer either on stable highly active anti-retroviral therapy (HAART) or not on HAART.
  • No changes in antiretroviral regimen within the prior 3 months.
  • Inclusion criteria for non-HIV infected control subjects arm:
  • Healthy men and women age 18-60
  • BMI 20-35

Who cannot join

  • Previously diagnosed coronary artery disease, cerebrovascular disease, or peripheral vascular disease.
  • Use of glucocorticoids, growth hormone, testosterone, or other anabolic agents within past 6 months
  • Renal disease or creatinine >1.5 mg/dL
  • Anti-inflammatory medications
  • Opportunistic infection within past 6 months in HIV infected individuals and current acute infectious illness in both HIV-infected subjects and normal controls.
  • Nitrates or others medications that can alter endothelial function
Show all 12Show fewer
  • Contraindication to beta-blocker use
  • Body weight greater than 300 lbs due to DEXA scanner table limitations
  • Patients with previous allergic reactions to iodine-containing contrast media or to iodine will be excluded from participation
  • Active illicit drug use
  • Pregnancy or breastfeeding
  • Estrogen or progestin use

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

We will obtain data using multi-slice CT technology to detect subclinical coronary disease in the HIV population. Determination of subclinical cardiovascular disease using noninvasive technology and elucidation of the associated risk factors will help to guide targeted therapy to prevent cardiovascular events in this patient population.

We will investigate the prevalence of coronary plaque lesions and coronary artery calcifications in men and women with HIV disease as determined by 64-row multidetector computed tomography (MDCT) and MDCT coronary angiography in comparison to age-matched control subjects without HIV infection. We hypothesize that evidence of coronary artery calcification and coronary plaque lesions as seen by MDCT will be present in individuals with HIV more than non-HIV control subjects of the same age. We also hypothesize the degree of atherosclerosis will be increased in HIV patients compared to control subjects.

We will evaluate the metabolic and inflammatory factors associated with coronary artery disease in HIV-infected individuals. We hypothesize that traditional cardiac risk factors as well as metabolic and inflammatory changes associated with HIV and its treatment such as dyslipidemia, increased secretion of inflammatory markers, decreased adiponectin, increased insulin resistance and increased visceral fat may be associated with coronary artery disease in HIV-infected individuals.

Keywords
HIV, atherosclerosis
Medical subject headings
HIV Infections, Coronary Artery Disease, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00455793
Study groupRoleWhat they receive
1HIV
2Non-HIV infected controls

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Coronary Plaque

    Measured: Baseline

Secondary outcomes (1)

  1. Inflammatory indices, glucose homeostasis, body composition

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2007 (estimated)
  2. Study startJun 2006
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Cross-sectional
Enrolment
263 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00455793
Sponsor's protocol ID
2006-P-000238
Status last verified
Nov 2013
First submitted
2 Apr 2007
Last updated
2 Dec 2013
Results posted
No
Data monitoring committee
No

Publications

  • Sim JH, Sherman JB, Stanley TL, Corey KE, Fitch KV, Looby SE, Robinson JA, Lu MT, Burdo TH, Lo J. Pro-Inflammatory Interleukin-18 is Associated with Hepatic Steatosis and Elevated Liver Enzymes in People with HIV Monoinfection. AIDS Res Hum Retroviruses. 2021 May;37(5):385-390. doi: 10.1089/AID.2020.0177. Epub 2021 Jan 25.

    PubMed 33323025

  • Cheru LT, Saylor CF, Fitch KV, Looby SE, Lu M, Hoffmann U, Stanley TL, Lo J. Low vitamin D is associated with coronary atherosclerosis in women with HIV. Antivir Ther. 2019;24(7):505-512. doi: 10.3851/IMP3336.

    PubMed 31742564

  • Fourman LT, Saylor CF, Cheru L, Fitch K, Looby S, Keller K, Robinson JA, Hoffmann U, Lu MT, Burdo T, Lo J. Anti-Inflammatory Interleukin 10 Inversely Relates to Coronary Atherosclerosis in Persons With Human Immunodeficiency Virus. J Infect Dis. 2020 Feb 3;221(4):510-515. doi: 10.1093/infdis/jiz254.

    PubMed 31077265

  • Weiss JJ, Sanchez L, Hubbard J, Lo J, Grinspoon SK, Fitch KV. Diet Quality Is Low and Differs by Sex in People with HIV. J Nutr. 2019 Jan 1;149(1):78-87. doi: 10.1093/jn/nxy241.

    PubMed 30624677

  • Cheru LT, Park EA, Saylor CF, Burdo TH, Fitch KV, Looby S, Weiner J, Robinson JA, Hubbard J, Torriani M, Lo J. I-FABP Is Higher in People With Chronic HIV Than Elite Controllers, Related to Sugar and Fatty Acid Intake and Inversely Related to Body Fat in People With HIV. Open Forum Infect Dis. 2018 Nov 5;5(11):ofy288. doi: 10.1093/ofid/ofy288. eCollection 2018 Nov.

    PubMed 30515430

  • Srinivasa S, Fitch KV, Torriani M, Zanni MV, Defilippi C, Christenson R, Maehler P, Looby SE, Lo J, Grinspoon SK. Relationship of visceral and subcutaneous adipose depots to markers of arterial injury and inflammation among individuals with HIV. AIDS. 2019 Feb 1;33(2):229-236. doi: 10.1097/QAD.0000000000002060.

    PubMed 30325779

  • Zanni MV, Stone LA, Toribio M, Rimmelin DE, Robinson J, Burdo TH, Williams K, Fitch KV, Lo J, Grinspoon SK. Proprotein Convertase Subtilisin/Kexin 9 Levels in Relation to Systemic Immune Activation and Subclinical Coronary Plaque in HIV. Open Forum Infect Dis. 2017 Oct 14;4(4):ofx227. doi: 10.1093/ofid/ofx227. eCollection 2017 Fall.

    PubMed 29226174

  • Srinivasa S, Lu MT, Fitch KV, Hallett TR, O'Malley TK, Stone LA, Martin A, Coromilas AJ, Burdo TH, Triant VA, Lo J, Looby SE, Neilan TG, Zanni MV. Epicardial adipose tissue volume and cardiovascular risk indices among asymptomatic women with and without HIV. Antivir Ther. 2018;23(1):1-9. doi: 10.3851/IMP3193.

    PubMed 28930079

  • Fitch KV, DeFilippi C, Christenson R, Srinivasa S, Lee H, Lo J, Lu MT, Wong K, Petrow E, Sanchez L, Looby SE, Hoffmann U, Zanni M, Grinspoon SK. Subclinical myocyte injury, fibrosis and strain in relationship to coronary plaque in asymptomatic HIV-infected individuals. AIDS. 2016 Sep 10;30(14):2205-14. doi: 10.1097/QAD.0000000000001186.

    PubMed 27314177

  • Looby SE, Fitch KV, Srinivasa S, Lo J, Rafferty D, Martin A, Currier JC, Grinspoon S, Zanni MV. Reduced ovarian reserve relates to monocyte activation and subclinical coronary atherosclerotic plaque in women with HIV. AIDS. 2016 Jan 28;30(3):383-93. doi: 10.1097/QAD.0000000000000902.

    PubMed 26696388

  • Zanni MV, Kelesidis T, Fitzgerald ML, Lo J, Abbara S, Wai B, Marmarelis E, Hernandez NJ, Yang OO, Currier JS, Grinspoon SK. HDL redox activity is increased in HIV-infected men in association with macrophage activation and non-calcified coronary atherosclerotic plaque. Antivir Ther. 2014;19(8):805-811. doi: 10.3851/IMP2756. Epub 2014 Feb 17.

    PubMed 24535655

  • Fitch KV, Srinivasa S, Abbara S, Burdo TH, Williams KC, Eneh P, Lo J, Grinspoon SK. Noncalcified coronary atherosclerotic plaque and immune activation in HIV-infected women. J Infect Dis. 2013 Dec 1;208(11):1737-46. doi: 10.1093/infdis/jit508. Epub 2013 Sep 16.

    PubMed 24041790

  • Hwang JJ, Wei J, Abbara S, Grinspoon SK, Lo J. Receptor activator of nuclear factor-kappaB ligand (RANKL) and its relationship to coronary atherosclerosis in HIV patients. J Acquir Immune Defic Syndr. 2012 Nov 1;61(3):359-63. doi: 10.1097/QAI.0b013e31826a6c16.

    PubMed 22842843

  • Burdo TH, Lo J, Abbara S, Wei J, DeLelys ME, Preffer F, Rosenberg ES, Williams KC, Grinspoon S. Soluble CD163, a novel marker of activated macrophages, is elevated and associated with noncalcified coronary plaque in HIV-infected patients. J Infect Dis. 2011 Oct 15;204(8):1227-36. doi: 10.1093/infdis/jir520.

    PubMed 21917896

  • Lo J, Abbara S, Rocha-Filho JA, Shturman L, Wei J, Grinspoon SK. Increased epicardial adipose tissue volume in HIV-infected men and relationships to body composition and metabolic parameters. AIDS. 2010 Aug 24;24(13):2127-30. doi: 10.1097/QAD.0b013e32833c055a.

    PubMed 20588167

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections and Coronary Atherosclerosis, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Coronary Plaque (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00455793, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2013.

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