Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of Pitavastatin on Lipid Profiles in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir: A Randomized, Double-blind, Crossover Study
Brief Summary: Dyslipidemia as a risk factor for cardiovascular disease (CVD) is an increasing problem in HIV-infected patients who are on antiretroviral therapy especially protease inhibitors including atazanavir. Pitavastatin is a new HMG-CoA reductase inhibitor with lesser drug-drug interactions and demonstrable efficacy in decreasing lipid levels in non HIV-infected individuals. The study was conducted as a randomized, double-blind, crossover study comparing the safety and efficacy of pitavastatin versus placebo in HIV-infected patients with dyslipidemia and receiving atazanavir/ritonavir. Patients were randomized to receive either placebo or pitavastatin for 12 weeks, underwent a 2-week washout period, and then were given the other treatment for an additional 12 weeks. Patients were observed for lipid profiles including total cholesterol (TC), triglyceride (TG), low density lipoprotein (LDL) and high density lipoprotein (HDL); and the side effects including clinical and laboratory (serum aspartate aminotransferase (AST), alanine aminotransferase (ALT) and creatinine phosphokinase (CPK)). The follow-up visits were every 4 weeks until the end of the study.


Options:
A: Inclusion Criteria:

* aged ≥18 years
* able to provide informed consent
* had confirmed HIV infection
* on ART including atazanavir 300 mg and ritonavir 100 mg each day in the regimens that were not changed within 12 weeks before the randomization
* patients who had cholesterol level between 200 and 500 and LDL between 130 and 400 mg/dL without any lipid-lowering agent or discontinued the lipid-lowering agent at least 1 month prior to randomization

Exclusion Criteria:

* had the history of pitavastatin and/or the constituent of the drugs allergy
* known history of myocardial infarction and/or ischemic stroke within 1 month prior to the randomization that would be endangered if we stopped the previous lipid-lowering agent before the enrollment
* abnormal AST and ALT with level ≥5 times in asymptomatic patients or ≥3 times of upper normal limit (UNL) in symptomatic patients
* pregnancy or breastfeeding
* on cyclosporine which had major drug interactions with pitavastatin
* patients who denied to join the study
B: Inclusion Criteria:

* Patient aged ≥ 20 years old and \< 75 years old.
* Patient who was eligible and able to participate in the study and accepts to enter the study by signing written informed consent.
* Patient with fasting LDL-C \> 100 mg/dL. The concentration of LDL-C is obtained from laboratory examination.
* Patient with at least one of the following description (NCEP ATP III guideline).
* Female patient with child-bearing potential must take reliable contraception method(s) during the participation of the study.

Exclusion Criteria:

* Patient who has participated in other investigational studies within 3 months.
* Patient took medication and natural health foods known to alter blood lipid profiles within 4 weeks.
* Patient is taking any medication or food that is prohibited by the study.
* Patient taking Amiodarone will be excluded from this study (due to long half life of this medication).
* Patient is diagnosed with type 1 DM or has been using insulin/insulin analog medication.
* Patient with a history of multiple drug allergies or with a known allergy to HMG-CoA reductase inhibitors.
* Patient with TG \> 400 mg/dL.
* Excessive obesity defined as BMI above 35 kg/m2.
* Cerebral vascular disease (including cerebrovascular hemorrhage or ischemia, transient ischemic attack) diagnosed within 3 months.
* Myocardial infarction, heart failure (NYHA class III or IV), gross cardiac enlargement (cardiothoracic ratio \> 0.5), significant heart block or cardiac arrhythmias within 3 months; history of uncontrolled complex ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardia, pacemaker or implantable cardiac device were not eligible for this study.
* Patient with advanced renal disorder (Serum creatinine levels ≥ 2 mg/dL and BUN ≥ 25 mg/dL).
* Patient with advanced hepatic disorder (AST or ALT level ≥ 100 IU/L)
* Patient with CK level \> 5 × ULRR at any time point between Visit 1 and Visit 2.
* Patient with poorly controlled diabetes mellitus (HbA1c \> 9.0%) or patient with severe hypertension (\> 180 mmHg for systolic or \> 120 mmHg in diastolic blood pressure).
* Patient with hypothyroidism, hereditary muscular disorders, family history of the above or history of drug-induced myopathy.
* Patient has significant alcohol consumption (\> 65 mL pure alcohol) within 48 hours before Visit 2.
* Any major surgery within 3 months prior to Visit 2.
* Female patient who is lactating, being pregnant or plans to become pregnant.
* Patient with conditions judged by the investigator as unsuitable for the study.
C: Inclusion Criteria:

* Males and females (18-75 years)
* Must have been following a restrictive diet
* Diagnosis of primary hypercholesterolemia or combined dyslipidemia

Exclusion Criteria:

* Homozygous familial hypercholesterolemia or familial hypoalphalipoproteinemia;
* Conditions which may cause secondary dyslipidemia.
* Uncontrolled diabetes mellitus (by hemoglobin A1c \[HbA1c\] \> 8%)
* Abnormal serum creatine kinase (CK) above the pre-specified level
* Abnormal pancreatic, liver or renal function
* Significant heart disease
D: Inclusion Criteria:

* Males and postmenopausal females (aged 65 years and older
* Eligible, able to participate, have given informed consent
* Must have been following a restrictive diet
* Diagnosis of primary hypercholesterolemia or combined dyslipidemia
* Serum CK must be less than or equal to 1.5 x ULRR at 2 of 3 permitted evaluations between Week -4 and -1
* Agree to be available

Exclusion Criteria

* Homozygous familial hypercholesterolemia
* Conditions which may cause secondary dyslipidemia
* Uncontrolled diabetes mellitus (HbA1c \>8%).
* Any condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug.
* History of pancreatic injury or pancreatitis, or impaired pancreatic function/injury
* Liver injury
* Impaired renal function
* Current obstruction of the urinary tract or difficulty in voiding due to mechanical as well as inflammatory conditions, which is likely to require intervention during the course of the study or is regarded as clinically meaningful
* Serum CK \>5 x ULRR without clinical explanation
* Uncontrolled hypothyroidism defined as TSH \>ULRR
* Any severe acute illness or severe trauma in the last 3 months prior to Visit 1
* Major surgery, 3 months prior to Visit 1
* Significant CVD prior to randomization
* Evidence of symptomatic heart failure, gross cardiac enlargement; significant heart block or cardiac arrhythmias. History of uncontrolled complex ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardias with a ventricular response rate of \> 100 beats per minute at rest.
* Left ventricular ejection fraction \<0.25;
* History of symptomatic cerebrovascular disease
* Any other conditions at the discretion of the investigator
* Known HIV infection
* Poorly controlled or uncontrolled hypertension
* Prior or current known muscular or neuromuscular disease of any type;
* Neoplastic disease
* Drug abuse or continuous consumption of more than 65 mL pure alcohol per day
* Exposure to any investigational new drug within 30 days of study entry or ingestion of any drug known to be toxic to a major organ system
* Current or recent use of supplements known to alter lipid metabolism
* History of hypersensitivity to other HMG-CoA reductase inhibitors;
* Concomitant medication not permitted
* Resistant to lipid-lowering medications. Known hypersensitivity or intolerance to any lipid lowering agent
* Excessive obesity
* Any factor which makes regular clinic attendance in the morning impractical ---Signs of mental dysfunction or other factors likely to limit ability to cooperate with the study.

Answer: A