Status:
COMPLETED
Evaluating an Exercise Program to Reduce Cardiovascular Risk Factors in Children Infected With HIV
Lead Sponsor:
University of Miami
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
HIV
Acquired Immunodeficiency Syndrome
Eligibility:
All Genders
2-25 years
Phase:
NA
Brief Summary
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 cardiovascul...
Detailed Description
People infected with HIV are now living longer and healthier lives than HIV-infected people of previous generations because of the widespread use of HAART medications. However, as HIV infection become...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00908284
Start Date
December 1 2008
End Date
November 1 2015
Last Update
December 7 2015
Active Locations (1)
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1
University of Miami, Department of Pediatrics, Division of Clinical Research, Batchelor Children's Research Institute
Miami, Florida, United States, 33136