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


N/A
1 Month
12 Years
Not Enrolling
Both
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
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.

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:

Observational

Study Design:

N/A

Principal Investigator

Caroline Chantry

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

P1010

NCT ID:

NCT00006064

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

Name

Location

Bellevue Hosp / New York Univ Med CtrNew York, New York  10016
Los Angeles County - USC Med CtrLos Angeles, California  90033
Baystate Med Ctr of SpringfieldSpringfield, Massachusetts  01199
Bronx Municipal Hosp Ctr/Jacobi Med CtrBronx, New York  10461
Duke Univ Med CtrDurham, North Carolina  27710
Texas Children's Hosp / Baylor UnivHouston, Texas  77030
Cook County HospChicago, Illinois  60612
Univ of Medicine & Dentistry of New Jersey / Univ HospNewark, New Jersey  071032714
North Shore Univ HospManhasset, New York  11030
Harlem Hosp CtrNew York, New York  10037
Columbia Presbyterian Med CtrNew York, New York  100323784
Univ of Miami (Pediatric)Miami, Florida  33161
Chicago Children's Memorial HospChicago, Illinois  606143394
Med Univ of South CarolinaCharleston, South Carolina  294253312
Med College of GeorgiaAugusta, Georgia  30912
Bronx Lebanon Hosp CtrBronx, New York  10456
Univ of Maryland at Baltimore / Univ Med CtrBaltimore, Maryland  21201
Children's Hosp of DenverDenver, Colorado  802181088
Children's Hosp of Washington DCWashington, District of Columbia  200102916
Emory Univ Hosp / PediatricsAtlanta, Georgia  30306
Harbor - UCLA Med CtrTorrance, California  90502
Univ of Rochester Med CtrRochester, New York  14642
Schneider Children's HospNew Hyde Park, New York  11040
Univ of Alabama at Birmingham - PediatricBirmingham, Alabama  35233
Phoenix Childrens HospPhoenix, Arizona  85006
Children's Hosp of OaklandOakland, California  946091809
Univ of California, San DiegoSan Diego, California  92103
Yale Univ Med SchoolNew Haven, Connecticut  06504
Howard Univ HospWashington, District of Columbia  20060
North Broward Hosp DistrictFort Lauderdale, Florida  33311
Univ of Florida GainesvilleGainesville, Florida  32610
Univ of Florida Health Science Ctr / PediatricsJacksonville, Florida  32209
Palm Beach County Health DeptRiviera Beach, Florida  33404
The Med Ctr IncColumbus, Georgia  31901
Univ of Illinois College of Medicine / PediatricsChicago, Illinois  60612
Univ of Chicago Children's HospChicago, Illinois  606371470
Johns Hopkins Hosp - PediatricBaltimore, Maryland  212874933
Children's Hosp of BostonBoston, Massachusetts  021155724
Boston City Hosp / PediatricsBoston, Massachusetts  02118
Univ of Massachusetts Med SchoolWorcester, Massachusetts  016550001
UMDNJ - Robert Wood Johnson Med School / PediatricsNew Brunswick, New Jersey  089030019
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med SchlNewark, New Jersey  07103
Metropolitan Hosp CtrNew York, New York  10029
Incarnation Children's Ctr / Columbia Presbyterian Med CtrNew York, New York  10032
State Univ of New York at Stony BrookStony Brook, New York  117948111
SUNY Health Sciences Ctr at Syracuse / PediatricsSyracuse, New York  13210
Saint Jude Children's Research Hosp of MemphisMemphis, Tennessee  381052794
Med College of VirginiaRichmond, Virginia  23219