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Home > "T" Clinical Trials Conditions > The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children  The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children
The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children
For Condition: Lipodystrophy,HIV Infections,HIV Wasting Syndrome
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: 1 Month/12 Years
Genders: Both
Protocol Entry 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.)
Total Enrollment: 100
Location and Contact Information:
Overall Study Official:
CarolineChantry, Study Chair,
Phoenix Childrens Hosp
Phoenix, Arizona, 85006
United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
United States
Med College of Georgia
Augusta, Georgia, 30912
United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306
United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, 089030019
United States
Univ of Rochester Med Ctr
Rochester, New York, 146420001
United States
Metropolitan Hosp Ctr
New York City, New York, 10029
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
Harbor - UCLA Med Ctr
Torrance, California, 90509
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
The Med Ctr Inc
Columbus, Georgia, 31901
United States
North Shore Univ Hosp
Great Neck, New York, 11021
United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, , 00956
Puerto Rico
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
Yale Univ Med School
New Haven, Connecticut, 06504
United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
United States
North Broward Hosp District
Ft. Lauderdale, Florida, 33311
United States
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233
United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
United States
Univ of California, San Diego
San Diego, California, 92103
United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, 07103
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
Palm Beach County Health Dept
Riviera Beach, Florida, 33404
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Schneider Children's Hosp
New Hyde Park, New York, 11040
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Med College of Virginia
Richmond, Virginia, 23219
United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612
United States
Univ of Florida Gainesville
Gainesville, Florida, 32610
United States
Children's Hosp of Oakland
Oakland, California, 946091809
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
Additional Information:
Study ID Numbers: ACTG P1010; PACTG P1010
Study Start Date: June 2000
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006064
Other Hiv Infections Studies:
1. Study of Alpha-2 Adrenergic Receptor Dysfunction in Regional Lipoatrophy
2. A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients
3. Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV Patients
4. Leptin to Treat Lipodystrophy
5. The Effect of Efavirenz and Nelfinavir on the Blood Levels of Certain Lipid-Lowering Drugs
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other Great Neck Clinical Trials
The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children
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