Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prospective Randomized Pilot Study of the Effect of Niaspan on Endothelial Function in HIV-infected Subjects With Low HDL Cholesterol Levels
Brief Summary: This study is a pilot study examining the effect of extended-release niacin (Niaspan ®) on flow-mediated vasodilation (FMD) of the brachial artery, among human immunodeficiency virus (HIV)-1 infected individuals with low high density lipoprotein (HDL). Brachial artery diameter will be measured by high-resolution ultrasound at entry and week 12 of study. The primary comparisons will be change in FMD from baseline to 12 weeks within each of the two arms. The second specific aim will be to investigate the proportion of the effect of extended-release niacin on other known cardiovascular markers.


Options:
A: Inclusion Criteria:

* HIV infected
* HIV-RNA \< 400 copies/ml at study entry and for 12 wks. prior
* 25-hydroxyvitamin D level \<20
* On a stable anti-retroviral (ARV) regimen for at least 12 weeks prior to study entry

Exclusion Criteria:

* Pregnancy or Breast Feeding
* Diabetes
* Creatinine Clearance \<50
* Any active infectious or inflammatory condition
* aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5 within 6 months prior to study entry
B: Inclusion Criteria:

* Age ≥18 years
* Documented HIV infection
* Subjects must have taken HAART 6 months prior to study entry and must be on stable HAART (no dose change to antiretroviral medications) for at least 30 days immediately prior to study entry
* HDL \< 40 mg/dL • LDL \< 130 mg/dL
* All subjects with reproductive potential should utilize adequate contraception for the duration of this study and for at least 12 weeks following permanent discontinuation of study treatment. Acceptable methods include male condom, female condom, diaphragm, or intra-uterine device (IUD)

Exclusion Criteria:

* Known cardiac disease
* Arrhythmia
* History of angina
* Uncontrolled hypertension
* Pregnancy
* Breast-feeding
* Medication known to influence vasodilatation such as nitrates, metformin, pioglitazone, and rosiglitazone
* Heavy use of vitamin supplements
* Diagnosis of diabetes mellitus
* Treatment with lipid-lowering drugs within 6 weeks prior to study
* Hemoglobin \<9.0 mg/dL
* Absolute neutrophil count \<750 cells/mm3
* Platelet count \<75,000 platelets/ mm3
* Alanine aminotransferase (ALT or SGOT)/ aspartate aminotransferase (AST or SGPT) / alkaline phosphatase \> 2.5 x upper limit of normal (ULN)
* Creatinine \>1.5 x ULN
* Individuals with an infection or other medical illness requiring hospitalization within 14 days prior to study entry
* Individuals who have active alcohol or drug abuse which, in the investigator's opinion, is sufficient to prevent adequate compliance with study therapy and evaluations
* Prior history of hypersensitivity reaction to niacin or any other component of the study drug
C: 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
D: Inclusion Criteria:

Subject, parent, or legal guardian able and willing to provide informed consent/assent.

Subject able and willing to comply with requirements of study HIV-infected subjects must have diagnosis confirmed with one or more of the following tests: 1) HIV DNA Polymerase chain reaction or HIV culture performed at any age; 2) Age \>18 months, licensed ELISA with confirmatory Western Blot.

Exclusion Criteria:

Patients with history of atraumatic fractures, known renal or liver disease, known malabsorption syndrome, or inflammatory bowel disease.

Use of corticosteroids, exculding inhaled steroids (current or within past 6 months) Current use of anticonvulsant drug Daily cigarette smoking Daily consumption of alcohol containing beverages Current use of tenofovir

Answer: B