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The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children
This study is ongoing, but not recruiting participants.
First Received: June 16, 2000   Last Updated: August 6, 2008   History of Changes
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00006064
  Purpose

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.


Condition
HIV Infections
HIV Wasting Syndrome
Lipodystrophy

Study Type: Observational
Official Title: Effect of Antiretroviral Therapy on Body Composition in HIV-Infected Children

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 100
Study Start Date: June 2000
Detailed Description:

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

Ages Eligible for Study:   1 Month to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006064

  Hide Study Locations
Locations
United States, Alabama
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, United States, 35233
United States, Arizona
Phoenix Childrens Hosp
Phoenix, Arizona, United States, 85006
United States, California
Children's Hosp of Oakland
Oakland, California, United States, 946091809
Univ of California, San Diego
San Diego, California, United States, 92103
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
Harbor - UCLA Med Ctr
Torrance, California, United States, 90509
United States, Colorado
Children's Hosp of Denver
Denver, Colorado, United States, 802181088
United States, Connecticut
Yale Univ Med School
New Haven, Connecticut, United States, 06504
United States, District of Columbia
Howard Univ Hosp
Washington, District of Columbia, United States, 20060
Children's Hosp of Washington DC
Washington, District of Columbia, United States, 200102916
United States, Florida
Univ of Miami (Pediatric)
Miami, Florida, United States, 33161
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States, 32209
North Broward Hosp District
Fort Lauderdale, Florida, United States, 33311
Univ of Florida Gainesville
Gainesville, Florida, United States, 32610
Palm Beach County Health Dept
Riviera Beach, Florida, United States, 33404
United States, Georgia
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, United States, 30306
Med College of Georgia
Augusta, Georgia, United States, 30912
The Med Ctr Inc
Columbus, Georgia, United States, 31901
United States, Illinois
Chicago Children's Memorial Hosp
Chicago, Illinois, United States, 606143394
Cook County Hosp
Chicago, Illinois, United States, 60612
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, United States, 60612
Univ of Chicago Children's Hosp
Chicago, Illinois, United States, 606371470
United States, Maryland
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, United States, 21201
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, United States, 212874933
United States, Massachusetts
Children's Hosp of Boston
Boston, Massachusetts, United States, 021155724
Boston City Hosp / Pediatrics
Boston, Massachusetts, United States, 02118
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States, 01199
Univ of Massachusetts Med School
Worcester, Massachusetts, United States, 016550001
United States, New Jersey
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States, 071032714
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, United States, 089030019
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States, 07103
United States, New York
Harlem Hosp Ctr
New York, New York, United States, 10037
Metropolitan Hosp Ctr
New York, New York, United States, 10029
Schneider Children's Hosp
New Hyde Park, New York, United States, 11040
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, United States, 10461
North Shore Univ Hosp
Great Neck, New York, United States, 11021
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, United States, 13210
Bronx Lebanon Hosp Ctr
Bronx, New York, United States, 10457
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
State Univ of New York at Stony Brook
Stony Brook, New York, United States, 117948111
Univ of Rochester Med Ctr
Rochester, New York, United States, 146420001
United States, North Carolina
Duke Univ Med Ctr
Durham, North Carolina, United States, 277103499
United States, South Carolina
Med Univ of South Carolina
Charleston, South Carolina, United States, 294253312
United States, Tennessee
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, United States, 381052794
United States, Texas
Texas Children's Hosp / Baylor Univ
Houston, Texas, United States, 77030
United States, Virginia
Med College of Virginia
Richmond, Virginia, United States, 23219
Puerto Rico
San Juan City Hosp
San Juan, Puerto Rico, 009367344
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, Puerto Rico, 009365067
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, Puerto Rico, 00956
Sponsors and Collaborators
Investigators
Study Chair: Caroline Chantry
Study Chair: Joseph Cervia
  More Information

Additional Information:
No publications provided

Study ID Numbers: ACTG P1010, PACTG P1010
Study First Received: June 16, 2000
Last Updated: August 6, 2008
ClinicalTrials.gov Identifier: NCT00006064     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
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

Additional relevant MeSH terms:
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Disease
Metabolic Diseases
Slow Virus Diseases
Skin Diseases
Immune System Diseases
HIV Wasting Syndrome
Acquired Immunodeficiency Syndrome
Infection
Immunologic Deficiency Syndromes
Virus Diseases
Pathologic Processes
Skin Diseases, Metabolic
HIV Infections
Syndrome
Lipodystrophy
Sexually Transmitted Diseases
Lentivirus Infections
Nutrition Disorders
Wasting Syndrome
Retroviridae Infections
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on November 27, 2009