Please select the eligibility criteria that correspond to the clinical trial below.
Title: Diet/Exercise, Niacin, Fenofibrate for HIV Lipodystrophy
Brief Summary: This study will evaluate the efficacy of diet and exercise (DE), with and without niacin and fenofibrate, in reducing the cardiovascular risk of patients with HIV lipodystrophy or dyslipidemia.


Options:
A: Inclusion Criteria:

* Patient has primary Type II hyperlipidemia or mixed dyslipidemia.
* If the patient is currently taking a lipid modifying medication other than Zocor \& he/she is willing to discontinue this medication
* LDL-C levels and/or non HDL-C levels above normal.
* Reasonable compliance with a standard cholesterol-lowering diet for a minimum of 4 weeks prior to screening and for the duration of the study.

Exclusion Criteria:

* Patient has an allergy, hypersensitivity, or intolerance to niacin, statins, or their derivatives.
* HbA1c ≥ 9% in diabetic patients
B: Inclusion Criteria:

* HIV positive
* On stable HAART regimen for at least 6 months prior to study entry
* T-cell count greater than 100 and viral load less than 1,000 for at least 6 months prior to study entry
* Fasting triglyceride level greater than 150 mg/dl
* Body mass index (BMI) greater than 18.5 and less than 30
* Uses barrier contraception

Exclusion Criteria:

* Fasting triglyceride level greater than 1000 mg/dl
* BMI less than 18.5 or greater than 30
* Taking diabetic medication or HbA1c less than 7.0
* Use of lipid lowering medication in the 30 days prior to study entry
* Unable to exercise
* T-cell count less than 100
* Current medical condition that makes exercise unadvisable
* History of coronary artery disease (CAD)
* Use of dietary supplements (within 30 days of study entry) that may affect lipid levels including, but not limited to, the following:

  1. Omega-3 fatty acids
  2. L-Carnitine
  3. Soluble fiber supplements
  4. Guggul
  5. Garlic supplements
  6. Niacin greater than 25mg/d
  7. Oral liquid supplements
* Use of steroids, hormones, or testosterone (without diagnosis of hypogonadism, testosterone less than 300 ng/dl)
* Irregular periods
* Depo-Provera
* Hypo- or Hyperthyroidism
* Adrenal insufficiency
* Serum alanine or aspartate aminotransferase level greater than 3 times the upper limit of normal
* Alcohol abuse
* Renal insufficiency (creatinine level greater than 1.5 mg/dl)
* Coumadin therapy
* Pregnancy
* Peptic ulcer disease
* Cholelithiasis
* History of hyperuricemia
* History of myositis or rhabdomyolysis
* Known adverse reaction to niacin or fibrates
* Hepatitis C therapy
C: Inclusion Criteria:

* Patient with LDL-C of 130 through 190 mg/dL and Triglycerides less than or equal to 500 mg/dL
* Patient willing to be on a low-cholesterol diet

Exclusion Criteria:

* Pregnant or lactating women or intending to become pregnant
* Patient with sensitivity or intolerance to ezetimibe, simvastatin, or ezetimibe/simvastatin combination tablet
* Patient with sensitivity or intolerance ro niacin, any component or niacin extended release or aspirin
* Patient for whom discontinuation of existing lipid-lowering therapy treatment poses an unacceptable risk
D: Inclusion Criteria:

1. Age 18 years or greater
2. Willing and able to give informed consent. The patients must be able to comply with study procedures and follow-up.
3. Undergoing clinically-indicated coronary and SVG angiography
4. Have an intermediate SVG lesion (defined as a lesion 30-60% angiographic diameter stenosis) without previous percutaneous intervention, amenable to examination with IVUS. The lesion should have no thrombus or ulceration and should not be considered responsible for the patient's clinical presentation and referral for graft angiography.

Exclusion Criteria:

1. Known allergy to niacin
2. History of statin-induced myopathy
3. Positive pregnancy test or breast-feeding
4. Coexisting conditions that limit life expectancy to less than 12 months or that could affect a patient's compliance with the protocol
5. Uncontrolled fasting triglyceride levels ( 500 mg/dL)
6. Fasting LDL-C \>200 mg/dL
7. Fasting HDL-C \>60 mg/dL
8. Poorly controlled diabetes (glycosylated hemoglobin levels 10%)
9. Current active liver disease or hepatic dysfunction
10. AST or ALT \> 2x the upper limit of normal
11. Uncontrolled hypothyroidism (Thyroid Stimulating Hormone \>1.5 x upper limit of normal \[ULN\])
12. Unexplained creatine kinase elevations (\>3 x ULN)
13. Recent history of acute gout
14. Serum creatinine \> 2.5 mg/dL
15. HIV (due to potential anti-retroviral drug-interactions with niacin)
16. Use of high-dose, antioxidant vitamins (vitamins C, E, or beta-carotene) that may interfere with the HDL-raising effect of niacin
17. Severe peripheral arterial disease limiting vascular access
18. Referral for cardiac catheterization by a physician who is an investigator in the present study.
19. Symptoms consistent with moderate or greater severity of congestive heart failure (New York Heart Association - NYHA class III or IV) or whose most recent determination of left ventricular ejection fraction is \<25%
20. Uncontrolled hypertension, defined as either a resting diastolic blood pressure of ≥100 mmHg or a resting systolic blood pressure of ≥200 mmHg
21. History of allergic reaction to iodine-based contrast agents
22. Significant medical or psychological condition that, in the opinion of the investigator, may compromise the patient's safety or successful participation in the study

Answer: B