Cardiovascular Diseases Clinical Trial
Official title:
Atherosclerotic Risk and Response to Exercise Intervention in HIV+ Children
Verified date | December 2015 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
People infected with HIV are now living longer lives because of the use of highly active antiretroviral therapy (HAART). However, HAART medications have been shown to increase the risk of cardiovascular disease and metabolic dysfunction in adults. More research is needed on the effect of HAART in children. The purpose of this study is to assess cardiovascular risk factors in children infected with HIV who receive HAART medications and to determine the effectiveness of an exercise program on cardiovascular outcomes in these children.
Status | Completed |
Enrollment | 16 |
Est. completion date | November 2015 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A to 25 Years |
Eligibility |
Inclusion Criteria for Part 1 of the Study: HIV-Infected Children: - Must be between 2 weeks and 25 years old with known perinatally acquired HIV infection - Stable medical regimen for at least 3 months before study entry - Has not used antihypertensive, hypoglycemic, or lipid-lowering medications - Active opportunistic infection in the 3 months before study entry - Willing to participate in the study and sign the informed consent document Non-HIV-Infected Siblings/Friends/General Pediatric Control Group: - Demographically similar to HIV-infected participants - Not known to be HIV-infected - Meets all other entry criteria for HIV-infected participants Exclusion Criteria for Part 1 of the Study: - Documented diabetes mellitus managed with medications - Heart, kidney, liver, or muscle disease - Intercurrent illness at the time of study entry and baseline testing (person can be enrolled when the illness is resolved [e.g., upper respiratory infection]) Inclusion Criteria for Part 2 of the Study: - Must be enrolled in Part 1 of the study - Must be between 6 and 25 years old - Willing to participate in the exercise program and sign the informed consent document - Has medical clearance from physician to participate in the study Exclusion Criteria for Part 2 of the Study: - Unable to perform or understand exercise program - Currently taking medications that would prohibit participation in exercise programs (e.g., coumadin, heparin) - Heart, kidney, liver, or muscle disease - Anabolic steroid use in the 3 months before study entry (e.g., growth hormone) - Malignant arrhythmia - Has a pacemaker - Orthopedic problems that would prevent performance of any of the prescribed activities - Changes in metabolic stress testing that would make the exercise program unsafe, as determined by the reporting cardiologist (i.e., ischemic changes) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | University of Miami, Department of Pediatrics, Division of Clinical Research, Batchelor Children's Research Institute | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Miami | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | E-selectin, vascular cell adhesion molecule-1 (VCAM-1), P-selectin, fibrinogen, plasminogen activator inhibitor-1 (PAI-1), and monocyte chemoattractant protein-1 (MCP-1) | Measured at Year 3 | Yes | |
Primary | High sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), adiponectin, leptin, mitochondrial DNA (mtDNA), echocardiography, flow-mediated dilation (FMD), and carotid intima-media thickness (cIMT) | Measured at Year 3 | Yes | |
Primary | Body mass index (BMI), dual energy x-ray absorptiometry (DXA), bioelectrical impedance analysis (BIA), resting energy expenditure (REE), bone mineral density (BMD), lipid profiles, insulin and glucose strength, and fitness measures | Measured at Year 3 | Yes | |
Secondary | Age, sex, HIV disease stage, CD4 counts, viral load, and type and length of antiretroviral therapies | Measured at Year 3 | No |
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