HIV Infections Clinical Trial
Official title:
Effect of Antiretroviral Therapy on Body Composition in HIV-Infected Children
The purpose of this study is to see how beginning or changing anti-HIV medications affects
the body composition (weight, height, growth, body fat, and muscle mass, or fat and muscle
distribution) of HIV-infected children. This study also looks at how changes in body
composition relate to changes in viral load (level of HIV in the blood), CD4 cell counts,
height, and weight in HIV-infected children. This study also compares changes in body
composition to levels of cytokines (proteins in the body that affect some immune cells) in
HIV-infected children who are beginning or changing anti-HIV therapy.
Though studies have been done on adults, little is known about the effects of HIV infection
and anti-HIV drugs on body composition in children. One theory is that changes in body
composition can predict the failure of anti-HIV treatment. If this is true, body composition
measurements can be as useful as CD4+ cell counts in determining drug effectiveness.
Despite accumulating data in adults, little information is available regarding the effects
of HIV infection and antiretroviral therapy on body composition in children. Preliminary
information indicates that lean body mass is lost in preference to fat mass in HIV-infected
children, supporting the theory that failure to thrive in HIV infection is often cytokine
mediated. It can be hypothesized that changes in body composition (lean body mass) may
predict changes in weight growth velocity and may give an early clinical indication of
treatment failure. If so, body composition measurement may yield an additional outcome
measure for clinical trials, equivalent in utility to other laboratory measures of treatment
response, e.g., persistent CD4+ cell count changes. Additionally, if body composition
changes are highly correlated with responses in viral load, body composition may prove to be
a more affordable measure of antiretroviral effectiveness in developing countries.
This study is a nonrandomized, observational study. Children are recruited to each of 4 age
strata:
Stratum A: 1 month to 18 months. Stratum B: greater than 18 months to 3 years. Stratum C:
greater than 3 years to 8 years. Stratum D: greater than 8 years to less than 13 years.
Children beginning or changing antiretroviral therapy and fulfilling the study
specifications may be enrolled in the study. Children have 5 outpatient clinic visits, at
entry and at 12, 24, 36, and 48 weeks, for anthropometry, body composition by bioelectrical
impedance analysis, cytokine levels, viral load, CD4+ cell count, and markers of lipid and
glucose metabolism.
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