Status:
COMPLETED
Comparing Blood Vessel Endothelial Function in HIV-Infected People and Matched HIV-Uninfected People
Lead Sponsor:
Indiana University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Brief Summary
The blood vessels that carry blood from the heart to the rest of the body are normally capable of relaxing and constricting when needed to provide more or less blood to the body. The inability of bloo...
Detailed Description
Normally the insides of blood vessels either widen or narrow in response to the need for more or less blood flow. This is a function of the endothelial cells, which are the cells that line the inner l...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT00919724
Start Date
May 1 2009
End Date
May 1 2013
Last Update
July 15 2014
Active Locations (1)
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1
Infectious Diseases Research Center
Indianapolis, Indiana, United States, 46202