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.
Observational
N/A
Caroline Chantry
Study Chair
United States: Federal Government
P1010
NCT00006064
June 2000
February 2005
Name | Location |
---|---|
Bellevue Hosp / New York Univ Med Ctr | New York, New York 10016 |
Los Angeles County - USC Med Ctr | Los Angeles, California 90033 |
Baystate Med Ctr of Springfield | Springfield, Massachusetts 01199 |
Bronx Municipal Hosp Ctr/Jacobi Med Ctr | Bronx, New York 10461 |
Duke Univ Med Ctr | Durham, North Carolina 27710 |
Texas Children's Hosp / Baylor Univ | Houston, Texas 77030 |
Cook County Hosp | Chicago, Illinois 60612 |
Univ of Medicine & Dentistry of New Jersey / Univ Hosp | Newark, New Jersey 071032714 |
North Shore Univ Hosp | Manhasset, New York 11030 |
Harlem Hosp Ctr | New York, New York 10037 |
Columbia Presbyterian Med Ctr | New York, New York 100323784 |
Univ of Miami (Pediatric) | Miami, Florida 33161 |
Chicago Children's Memorial Hosp | Chicago, Illinois 606143394 |
Med Univ of South Carolina | Charleston, South Carolina 294253312 |
Med College of Georgia | Augusta, Georgia 30912 |
Bronx Lebanon Hosp Ctr | Bronx, New York 10456 |
Univ of Maryland at Baltimore / Univ Med Ctr | Baltimore, Maryland 21201 |
Children's Hosp of Denver | Denver, Colorado 802181088 |
Children's Hosp of Washington DC | Washington, District of Columbia 200102916 |
Emory Univ Hosp / Pediatrics | Atlanta, Georgia 30306 |
Harbor - UCLA Med Ctr | Torrance, California 90502 |
Univ of Rochester Med Ctr | Rochester, New York 14642 |
Schneider Children's Hosp | New Hyde Park, New York 11040 |
Univ of Alabama at Birmingham - Pediatric | Birmingham, Alabama 35233 |
Phoenix Childrens Hosp | Phoenix, Arizona 85006 |
Children's Hosp of Oakland | Oakland, California 946091809 |
Univ of California, San Diego | San Diego, California 92103 |
Yale Univ Med School | New Haven, Connecticut 06504 |
Howard Univ Hosp | Washington, District of Columbia 20060 |
North Broward Hosp District | Fort Lauderdale, Florida 33311 |
Univ of Florida Gainesville | Gainesville, Florida 32610 |
Univ of Florida Health Science Ctr / Pediatrics | Jacksonville, Florida 32209 |
Palm Beach County Health Dept | Riviera Beach, Florida 33404 |
The Med Ctr Inc | Columbus, Georgia 31901 |
Univ of Illinois College of Medicine / Pediatrics | Chicago, Illinois 60612 |
Univ of Chicago Children's Hosp | Chicago, Illinois 606371470 |
Johns Hopkins Hosp - Pediatric | Baltimore, Maryland 212874933 |
Children's Hosp of Boston | Boston, Massachusetts 021155724 |
Boston City Hosp / Pediatrics | Boston, Massachusetts 02118 |
Univ of Massachusetts Med School | Worcester, Massachusetts 016550001 |
UMDNJ - Robert Wood Johnson Med School / Pediatrics | New Brunswick, New Jersey 089030019 |
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl | Newark, New Jersey 07103 |
Metropolitan Hosp Ctr | New York, New York 10029 |
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr | New York, New York 10032 |
State Univ of New York at Stony Brook | Stony Brook, New York 117948111 |
SUNY Health Sciences Ctr at Syracuse / Pediatrics | Syracuse, New York 13210 |
Saint Jude Children's Research Hosp of Memphis | Memphis, Tennessee 381052794 |
Med College of Virginia | Richmond, Virginia 23219 |