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

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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

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

      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

Study Type



HIV Infections


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment


Start Date

June 2000

Completion Date

February 2005

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.)




1 Month - 12 Years

Accepts Healthy Volunteers



Caroline Chantry, , 

Location Countries

Puerto Rico

Location Countries

Puerto Rico

Administrative Informations



Organization ID


Secondary IDs


Responsible Party


Study Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)


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

Study Sponsor

Caroline Chantry, Study Chair, 

Verification Date

October 2014