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Effect of Antiretroviral Therapy on Body Composition in HIV-Infected Children

1 Month
12 Years
Not Enrolling
HIV Infections, HIV Wasting Syndrome, Lipodystrophy

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Trial Information

Effect of Antiretroviral Therapy on Body Composition in HIV-Infected Children

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

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.

Inclusion Criteria

Inclusion Criteria

Children may be eligible for this study if they:

- Are 1 month to 12 years old.

- Are HIV-1 positive.

- Have not begun puberty.

- Are beginning or changing anti-HIV therapy and:

- (1) have never used anti-HIV drugs and are starting any anti-HIV therapy; or (2) have
never used protease inhibitors (PIs) and are starting a PI-containing therapy; or (3)
have used PIs in the past and are changing anti-HIV treatment and have never used at
least 2 of the drugs in the new therapy.

- Have a parent or legal guardian able and willing to provide signed informed consent.

Exclusion Criteria

Children will not be eligible for this study if they:

- Have cancer.

- Use metal artificial body parts or electrical devices that have been inserted into
the body (such as a pacemaker).

- Have had an arm or leg removed.

- Have a physical disability that would prevent an accurate measurement of body height
or length.

- Have diabetes and need insulin.

- Have or have had a serious illness or fever in the 14 days before entering study
(except an upper respiratory infection without a fever).

- Have used steroids (corticosteroids, anabolic steroids, or megestrol acetate),
interleukin, interferon, thalidomide, or GH within 180 days before entering study.
Glucocorticoids are allowed as long as treatment did not occur during the 14 days
before entering study and total treatment in the 180 days before entering study was
not more than 15 days.

- Have used anti-HIV medication, if they are beginning any anti-HIV therapy.

- Have used PIs, if they are beginning a PI-containing regimen. (Prior use of PIs is
allowed if child is changing anti-HIV treatment and he/she has never used at least 2
of the drugs in the new therapy.)

Type of Study:


Study Design:


Principal Investigator

Caroline Chantry

Investigator Role:

Study Chair


United States: Federal Government

Study ID:




Start Date:

June 2000

Completion Date:

February 2005

Related Keywords:

  • HIV Infections
  • HIV Wasting Syndrome
  • Lipodystrophy
  • Tumor Necrosis Factor
  • CD4 Lymphocyte Count
  • Polymerase Chain Reaction
  • Enzyme-Linked Immunosorbent Assay
  • RNA, Messenger
  • Interleukin-1
  • Body Composition
  • Anti-HIV Agents
  • Viral Load
  • Age Factors
  • Anthropometry
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Lipodystrophy
  • Wasting Syndrome
  • HIV Wasting Syndrome



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Univ of Florida Health Science Ctr / Pediatrics Jacksonville, Florida  32209
Palm Beach County Health Dept Riviera Beach, Florida  33404
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Univ of Illinois College of Medicine / Pediatrics Chicago, Illinois  60612
Univ of Chicago Children's Hosp Chicago, Illinois  606371470
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Children's Hosp of Boston Boston, Massachusetts  021155724
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Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl Newark, New Jersey  07103
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Saint Jude Children's Research Hosp of Memphis Memphis, Tennessee  381052794
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