Comparing Blood Vessel Endothelial Function in HIV-Infected People and Matched HIV-Uninfected People

HIV-infected people will be recruited from infectious diseases outpatient clinics of Wishard Hospital and Indiana University Hospital. They will be enrolled in one of two other HIV trials. HIV-uninfected people will be recruited from the Indianapolis general population.

Inclusion Criteria for HIV-Infected Group:

• Positive HIV enzyme-linked immunosorbent assay (ELISA) test with confirmatory Western Blot
• Not currently receiving antiretroviral therapy

Inclusion Criteria for HIV-Uninfected Group:

• Negative HIV ELISA test at screening
• Within 10 years of age of the matched HIV-infected participant
• Same sex and current smoking status as the matched HIV-infected participant
• Height within 4 inches of the matched HIV-infected participant

Exclusion Criteria for All Participants:

• Inability to complete written informed consent
• Incarceration at the time of screening or main study visit
• Diagnosed vascular disease (e.g., history of angina pectoris, coronary disease, peripheral vascular disease, cerebrovascular disease, aortic aneurysm, or otherwise known atherosclerotic disease)
• Diagnosed disease or process associated with increased systemic inflammation (e.g., systemic lupus erythematosis, inflammatory bowel diseases, or other collagen vascular diseases); Note: Hepatitis B or C co-infections are not exclusionary
• History of bleeding diathesis, gastrointestinal ulceration or bleeding, cerebrovascular aneurysm or bleeding, or retinal hemorrhage
• Known or suspected cancer requiring systemic treatment within 6 months of screening
• History of diabetes mellitus, as defined by the American Diabetes Association; Note: History of gestational diabetes is not exclusionary
• History of migraine headaches
• History of Raynaud's phenomenon
• History of cardiac arrhythmias or cardiomyopathy
• History of hypothyroidism or hyperthyroidism, even if treated; Note: Use of caffeinated products, except on the mornings of the study visits, is not exclusionary
• Known allergy or intolerance to nitroglycerin
• History of carotid bruits
• Creatinine clearance less than 50mL/min, using a serum creatinine level measured at screening
• Hemoglobin level greater than 9.0g/dL at screening
• Alanine aminotransferase (ALT) level or aspartate aminotransferase (AST) greater than three times the upper limit of normal (ULN) at screening
• Total bilirubin greater than 2.5 times ULN at screening
• Fever, defined as a temperature greater than 38.0 C within 48 hours prior to screening
• Received therapy for acute infection or other serious medical illness within 14 days prior to screening
• Pregnant or breastfeeding during the course of the study
• Hypotension, defined as systolic blood pressure less than 90mm Hg, at screening.
• Uncontrolled hypertension
• Receipt of anti-inflammatory agents (e.g., plaquenil, infliximab, etanercept, mycophenolate mofetil, sirolimus, tacrolimus, cyclosporine, pentoxifylline, thalidomide)
• Receipt of investigational agents, cytotoxic chemotherapy, systemic or topical glucocorticoids (of any dose), or anabolic steroids within 28 days of screening; Note: Physiologic testosterone replacement therapy is not exclusionary
• Receipt of lipid-lowering drugs, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs), acetazolamide, anticoagulants, anticonvulsants, or thyroid replacements within 7 days prior to screening
• Use of sildenafil, vardenafil, or tadalafil within 72 hours (before or after) of each main study visit
• Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements