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

October 28, 2014 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00935
        • University of Puerto Rico Pediatric HIV/AIDS Research Program CRS
  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Jacobi Med. Ctr. Bronx NICHD CRS
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hosp. CRS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Study Chair: Caroline Chantry
  • Study Chair: Joseph Cervia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Study Completion (ACTUAL)

February 1, 2005

Study Registration Dates

First Submitted

June 16, 2000

First Submitted That Met QC Criteria

August 30, 2001

First Posted (ESTIMATE)

August 31, 2001

Study Record Updates

Last Update Posted (ESTIMATE)

October 29, 2014

Last Update Submitted That Met QC Criteria

October 28, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P1010
  • 10814 (DAIDS ES)
  • PACTG P1010
  • ACTG P1010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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