Please select the eligibility criteria that correspond to the clinical trial below.
Title: Role of Extended-release Niacin on Immune Activation in HIV-infected Patients Treated With Antiretroviral Therapy: a Proof-of-concept Study
Brief Summary: There are a number of powerful anti-HIV drugs, which keep the virus at undetectable levels and enable HIV-infected individuals to live longer. However, some participants taking anti-HIV drugs do not achieve an adequate CD4 recovery and remain at risk for developing AIDS and non-AIDS-related complications.

ER niacin (PrNiaspanFCT®) is an extended-released form of niacin, also known as vitamin B3. Niacin is effective in reducing cholesterol levels in the blood. This drug has been known for a long-time to treat dyslipidemia and it is used to improve favourably all the lipoprotein risk factors for artherosclerotic disease, particularly in HIV-infected patients. Recent scientific research shows that regular consumption of niacin-rich foods may also provide protection against Alzheimer's disease and age-related cognitive decline.

The purpose of this study is to find out:

1. If ER niacin combined with anti-HIV drugs, compared with anti-HIV drugs alone, could reduce T cell immune activation and enhance CD4 recovery;
2. If ER niacin can improve your quality of life and your neurocognitive functions


Options:
A: Inclusion Criteria:

* HIV infection
* Ages 5.0 to 50.9 y
* In usual state of good health
* Subject and/or family commitment to the 12-week study

Exclusion Criteria:

* Other chronic health conditions unrelated to HIV/AIDS that may affect nutritional status
* Use of vit D supplementation above 400 IU/d
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: Participants must meet all of the following criteria within four weeks prior to the Week 0 (Baseline) Visit to be considered eligible for entry into the study:

1. Documented HIV infection by Western Blot, EIA assays or viral load assay
2. Aged 21 or older
3. Viral load \< 50 copies/mL for the last 3 months
4. CD4 cell count \< 350 cells/µL
5. On stable ART, i.e., ART unchanged for treatment failure (rebound in viral load) for more than 12 months
6. Able to communicate adequately in either French or English
7. Able and willing to give written informed consent prior to enrolment including access to relevant medical records.

Participants are not eligible to participate in the study if any of the following conditions are met:

1. Pregnant, breastfeeding or planning to become pregnant during the course of the study. All fecund female participants must undergo a pregnancy test, with a negative result, prior to being eligible to participate in the study
2. Prior history of hypersensitivity reaction to niacin or any other component of the study drug
3. Prior history of flushing
4. Active liver disease or unexplained persistent elevations of serum transaminases
5. Co-infection with active Hepatitis B or C virus (positive HBs Ag or positive anti HBc antibodies with a detectable HBV DNA viral load or positive anti HCV antibodies with a detectable HCV RNA viral load)
6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or alkaline phosphatase \>2.5 x upper limit of normal (ULN)
7. Active duodenal or gastric peptic ulcer
8. Active bleeding disorders
9. History of gout
10. Active AIDS events in the last 3 months as determined by the treating physician
11. Unstable angina or acute phase myocardial infarction, with or without vasodilator agents
12. Diabetic or potentially diabetic with hypercholesterolaemia
13. Renal dysfunction.
D: Inclusion Criteria:

* Men and women, age 18 to 60 years inclusive
* At least two positive sputum smears for tuberculosis
* Intention to stay in Dar-es-Salaam for at least 2 years after the start of TB therapy
* Subjects who grant informed consent to participation

Exclusion Criteria:

* Karnofsky score \< 40%
* Hemoglobin \< 8.5 g/dl
* Having had treatment for TB exceeding 4 weeks in the last 5 years
* Pregnant women

Answer: C