| Conditions: |
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HIV - Acquired Immunodeficiency Syndrome - Cardiovascular Diseases |
| Purpose: |
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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.
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| Study Summary: |
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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 becomes a more chronic illness, rather than a fatal disease, researchers are
beginning to identify the long-term complications of HIV infection and its treatment. Adults
infected with HIV are increasingly developing the following: hyperlipidemia and
dyslipidemia, both of which are associated with high cholesterol levels; endothelial
dysfunction; insulin resistance; and changes in body composition, including increased
obesity levels and an increase in central body fat. These conditions are all associated with
an increased risk of cardiovascular disease. More research is needed to examine how children
infected with HIV who are receiving HAART may be affected by these conditions. In this
study, researchers will examine children infected with HIV who are receiving HAART (as well
as a control group of children who are not infected with HIV) to evaluate vascular function
and inflammation over time and how they affect body composition, fat redistribution, insulin
resistance, hyperlipidemia, growth, nutrition, bone metabolism, and disease severity. This
study will also evaluate the effectiveness of an exercise program on vascular function and
cardiovascular outcomes in children infected with HIV who are receiving HAART.
There are two parts to this study. In Part 1, children infected with HIV and their siblings
and friends who are not infected with HIV will attend study visits every 6 months for 3
years. At select visits, the following study procedures will occur: medical history review;
physical exam; blood collection; body measurements; questionnaires regarding diet, quality
of life, and activity levels; and an echocardiogram to obtain images of the heart.
In Part 2 of the study, a portion of participants from Part 1 of the study who are infected
with HIV will be randomly assigned to take part in a 12-week exercise program or a control
group. At a baseline study visit, all participants will undergo a medical history review,
fitness testing, body measurements, muscle and fat measurements, blood collection,
echocardiogram, questionnaires to assess quality of life and activity levels, and an
ultrasound of the brachial artery (on the upper arm) and carotid artery (on the neck) to
measure artery size.
Participants in the exercise program will exercise (e.g., walking, running, cycling,
stretching, and weight training) for 1 hour at the study exercise laboratory 2 days a week
for 12 weeks. If participants cannot come to the laboratory, they may exercise at home,
under the guidance of study researchers. Participants will wear a pedometer on select days
and keep an activity log to record how far they walk. At the end of the 12-week program,
participants will undergo repeat baseline testing. They will also receive a written,
personalized exercise program that they can follow on their own. Participants will receive
weekly phone calls from study researchers and will attend study visits once a month for 3
months for follow-up and monitoring. Baseline testing will occur again at the end of the
3-month follow-up period.
Participants in the control group will attend group sessions once a week for 12 weeks at
which time they will watch videos, including some exercise videos, and play games that do
not require physical activity. At the end of Week 12, participants will undergo repeat
baseline testing. They will then have the option of taking part in the exercise program.
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| Criteria: |
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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)
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| NCT ID: |
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NCT00908284 |
| Primary Contact: |
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Principal Investigator
Tracie L. Miller, MD
University of Miami
Gabriel Somarriba, BS
Phone: 305-243-4304
Email: gsomarriba2@med.miami.edu
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| Backup Contact: |
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Email: dnerialmeida@med.miami.edu
Daniela Neri-Almeida, MS, RD, LD
Phone: 305-243-6117
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| Location Contact: |
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Miami, Florida 33136
United States
Gabriel Somarriba, BS
Phone: 305-243-4304
Email: gsomarriba2@med.miami.edu
Site Status: Recruiting |