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OpenTrials
Completed

NCT Number: NCT00965185

Statin Therapy to Improve Atherosclerosis in HIV Patients

In HIV patients, statin therapy will attenuate plaque inflammation, thus, making plaques less vulnerable, will deter plaque progression, and improve endothelial function. In addition to known cholesterol-lowering and C-reactive protein lowering effects, immunomodulatory effects of statins will lead to a shift from pro-inflammatory monocyte and T cell subsets to less atherogenic subpopulations.

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Key information

Conditions

Cardiovascular Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Blood-Borne Infections Cardiovascular Diseases Communicable Diseases Genital Diseases HIV HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Inflammation Lentivirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Statins, HMG-CoA Urogenital Diseases Vascular Diseases Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women age 18-60 with previously diagnosed HIV disease
  • Subclinical coronary artery disease as defined by presence of one or more plaque on coronary CTA without history of cardiac events or cardiac symptoms and no evidence of critical coronary stenosis. Target to background ratio (TBR) as determined by PET of > 1.6.
  • Stable anti-retroviral (ARV) therapy as defined by no changes in ARV regimen for >6 months
  • LDL-cholesterol >70 mg/dL and <130 mg/dL

Exclusion criteria

  • History of acute coronary syndrome
  • Contraindication to statin therapy
  • Current statin use
  • AST or ALT two times greater than the upper limit of normal or receiving treatment for active liver disease
  • Renal disease or creatinine >1.5 mg/dL (given the risk of contrast nephropathy during CT angiography of the heart)
  • Infectious illness within past 3 months
  • Contraindication to beta-blocker (including moderate to severe asthma or heart block) or nitroglycerin use as these drugs are given as part of the standard cardiac CT protocol. Previous allergic reaction to beta blocker or nitroglycerin.
  • Body weight greater than 300 lbs due to CT scanner table limitations
  • Patients with previous allergic reactions to iodine-containing contrast media
  • Active illicit drug use
  • Patients who report any significant radiation exposure over the course of the year prior to randomization. Significant exposure is defined as:
  • More than 2 percutaneous coronary interventions (PCI) within 12 months of randomization
  • More than 2 myocardial perfusion studies within the past 12 months
  • More than 2 CT angiograms within the past 12 months
  • Any subjects with history of radiation therapy.
  • Patients already scheduled or being considered for a procedure or treatment requiring significant radiation exposure (e.g., radiation therapy, PCI, or catheter ablation of arrhythmia) within 12 months of randomization
  • Pregnancy or breastfeeding
  • Coronary artery luminal narrowing >70% seen on coronary CTA

Treatment and study plan

atorvastatin

Drug

20 mg PO QD for the first 3 months, followed by 40 mg PO QD for the final 9 months.

Placebo

Drug

Placebo

Primary outcomes

  1. Coronary and Aortic Plaque Inflammation

    Time frame: Measured at baseline and 1 year

    12 month change in mean FDG-PET TBR (18-fluorodeoxyglucose positron emission tomography target-to-background ratio)

Secondary outcomes

  1. Plaque Progression

    Time frame: Measured at baseline and 1 year

    12 month percent change in plaque volume

  2. Endothelial Function

    Time frame: 1 year

    Assessment of endothelial function was to be measured by endothelial vasodilator function.

  3. Immune Function

    Time frame: Measured at baseline and 1 year

    12 month change in CD4 T-lymphocytes

  4. Lipid Profile

    Time frame: Measured at baseline and 1 year

    12 month change in lipid profile

  5. C-reactive Protein (CRP)

    Time frame: Measured at baseline and 1 year

    12 month change in Log CRP concentration

  6. Adipocytokines

    Time frame: Measured at baseline and 1 year

    12 month change in IL-6

  7. Liver Function Tests (LFTs)

    Time frame: Measured at baseline, 1, 3, 6, 9, and 12 months

    Number of participants with LFT abnormalities (greater than or equal to 3 times the upper limit of normal).

    For reference, the normal ranges for AST and ALT are shown below. Please note that the normal range for ALT at Labcorp changed over the course of the study. AST and ALT elevations were determined based on the normal range at the time the lab test was performed.

    ALT: 0-40 IU/L, 0-44 IU/L, or 0-55 IU/L AST: 0-40 IU/L

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Statin Therapy to Improve Inflammation and Atherosclerosis in HIV Patients

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Aug 25, 2009
Registry last updated
Dec 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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