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The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children

Primary Purpose

HIV Infections, HIV Wasting Syndrome, Lipodystrophy

Status
Completed
Phase
Locations
International
Study Type
Observational
Intervention
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for HIV Infections focused on measuring 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

Eligibility Criteria

1 Month - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Jacobi Med. Ctr. Bronx NICHD CRS
  • Texas Children's Hosp. CRS
  • University of Puerto Rico Pediatric HIV/AIDS Research Program CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 16, 2000
Last Updated
October 28, 2014
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00006064
Brief Title
The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children
Official Title
Effect of Antiretroviral Therapy on Body Composition in HIV-Infected Children
Study Type
Observational

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, HIV Wasting Syndrome, Lipodystrophy
Keywords
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

7. Study Design

Enrollment
100 (false)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline Chantry
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Joseph Cervia
Official's Role
Study Chair
Facility Information:
Facility Name
Jacobi Med. Ctr. Bronx NICHD CRS
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Texas Children's Hosp. CRS
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Puerto Rico Pediatric HIV/AIDS Research Program CRS
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
18614924
Citation
Chantry CJ, Hughes MD, Alvero C, Cervia JS, Hodge J, Borum P, Moye J Jr; PACTG 1010 Team. Insulin-like growth factor-1 and lean body mass in HIV-infected children. J Acquir Immune Defic Syndr. 2008 Aug 1;48(4):437-43. doi: 10.1097/QAI.0b013e31817bbe6d.
Results Reference
result
PubMed Identifier
18519448
Citation
Chantry CJ, Hughes MD, Alvero C, Cervia JS, Meyer WA 3rd, Hodge J, Borum P, Moye J Jr; PACTG 1010 Team. Lipid and glucose alterations in HIV-infected children beginning or changing antiretroviral therapy. Pediatrics. 2008 Jul;122(1):e129-38. doi: 10.1542/peds.2007-2467. Epub 2008 Jun 2.
Results Reference
result
PubMed Identifier
20345880
Citation
Chantry CJ, Cervia JS, Hughes MD, Alvero C, Hodge J, Borum P, Moye J Jr; PACTG 1010 Team. Predictors of growth and body composition in HIV-infected children beginning or changing antiretroviral therapy. HIV Med. 2010 Oct 1;11(9):573-83. doi: 10.1111/j.1468-1293.2010.00823.x. Epub 2010 Mar 21.
Results Reference
result
PubMed Identifier
20631646
Citation
Cervia JS, Chantry CJ, Hughes MD, Alvero C, Meyer WA 3rd, Hodge J, Borum P, Moye J Jr, Spector SA; PACTG 1010 Team. Associations of proinflammatory cytokine levels with lipid profiles, growth, and body composition in HIV-infected children initiating or changing antiretroviral therapy. Pediatr Infect Dis J. 2010 Dec;29(12):1118-22. doi: 10.1097/INF.0b013e3181ed9f4c.
Results Reference
result

Learn more about this trial

The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children

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