Metabolism and Body Shape of Healthy Children and Children With Chronic Infections

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Brief Title

Metabolism and Body Shape of Healthy Children and Children With Chronic Infections

Official Title

Metabolism and Body Composition of Healthy Children and Children With Chronic Infections

Brief Summary

      Some HIV-infected adults develop lipodystrophy that includes significant changes in body
      shape, with fat losses in the face, arms and legs, and fat gain in the trunk. This
      lipodystrophy is often accompanied by other disorders of metabolism, such as increased levels
      of fat and insulin in the blood.

      The majority of these cases have been seen when patients are taking medications called
      protease inhibitors. These are anti-retroviral medications designed to treat patients with
      HIV. It is unclear if lipodystrophy is a result of having HIV or the medication used to treat
      HIV. It has been suggested, but not proven, that lipodystrophy is a direct side effect of
      protease inhibitors. In addition, it is unknown if HIV-infected children develop significant
      lipodystrophy after taking protease inhibitors.

      This study will investigate the prevalence of metabolic disorders and changes in body fat
      distribution in children taking protease inhibitor anti-retroviral medications. The results
      will be compared to three other groups; (1) children suffering from other non-HIV chronic
      infections, (2) HIV-infected children not taking protease inhibitors, and (3) healthy
      children.

      The study will look at HIV-infected children who have already started taking protease
      inhibitors. It will evaluate these children for disorders in metabolism as well as body fat
      changes. In addition, the study will follow HIV-infected children who will begin taking
      protease inhibitors. The study will follow these children for 18 months to detect the
      development of disorders in metabolism and / or body fat changes.
    

Detailed Description

      Some HIV-infected adults develop a lipodystrophy that includes significant changes in body
      shape, with fat loss in the face, arms and legs, and fat gain in the trunk. This
      lipodystrophy is often accompanied by hypertriglyceridemia, hypercholesterolemia, and
      hyperinsulinemia. So far, almost all cases of lipodystrophy have occurred in patients treated
      with protease inhibitor-containing antiretroviral therapies. Whether this lipodystrophy is a
      result of the use of protease inhibitors or other therapies employed for HIV infection, or is
      one of the many manifestations of HIV infection, and is unmasked by the longevity achieved by
      those treated with protease inhibitors remains uncertain. It has been suggested, although not
      proven, that this condition may be an adverse effect of protease inhibitor treatment. It is
      also unknown whether HIV-infected children develop significant lipodystrophy when exposed to
      protease inhibitors. We propose to investigate whether initiation of protease
      inhibitor-containing antiretroviral regimens in children with HIV infection affects the
      prevalence of dyslipidemia, insulin resistance, and alterations of body fat distribution, and
      to study the pathophysiology of these changes. The incidence of such abnormalities will be
      compared to children with non-HIV-related chronic infections, to HIV-infected children who
      are treated with protease inhibitor sparing regimen, and to healthy controls.

      This study has both cross-sectional and longitudinal components. Children with HIV infection,
      who are to begin taking protease inhibitors and who are already taking protease inhibitors as
      part of their treatment for HIV infection, will be recruited for a single cross-sectional
      evaluation that will include studies of lipid and glucose metabolism and body composition. In
      the longitudinal component, those children with HIV infection, who were studied before they
      began taking protease inhibitors, will be followed prospectively for 18 months to delineate
      further the relationships between treatment and the development of lipodystrophy and
      abnormalities in lipid and glucose metabolism. If the cross-sectional study does not show
      that the prevalence of lipodystrophy and its associated metabolic alterations increases as a
      function of exposure to protease inhibitors, we will terminate the prospective study. Changes
      in triglyceride levels, insulin levels, and regional body fat will be evaluated as primary
      outcome measures. As part of the evaluations performed during the cross-sectional and
      longitudinal studies, we will investigate the pathophysiology of dyslipidemia in HIV-infected
      children by assessing lipoproteins and their subclasses, apolipoproteins, and both
      lipoprotein lipase levels and activity.
    


Study Type

Observational




Condition

HIV Infections



Publications

* 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

185

Start Date

October 1999

Completion Date

December 2000


Eligibility Criteria

        FOR PROTEASE INHIBITOR-NAIVE HIV-INFECTED CHILDREN AND HIV-INFECTED CHILDREN ON PROTEASE
        INHIBITOR-CONTAINING ANTIRETROVIRAL REGIMENS:

        Evidence of HIV infection based on Center for Disease Control and Prevention criteria.

        Enrollment on protocol 98-C-0041 or other HIV treatment protocol for children.

        No other chronic disease unrelated to infection that may cause changes in body composition
        or in lipid or glucose homeostasis.

        No previous use of a protease inhibitor-containing antiretroviral regimen (PROTEASE
        INHIBITOR-NAIVE HIV-INFECTED CHILDREN ONLY).

        Data available concerning the start date of protease inhibitor treatment (HIV-INFECTED
        CHILDREN ON PROTEASE INHIBITOR-CONTAINING ANTIRETROVIRAL REGIMENS ONLY).

        HEALTHY PEDIATRIC VOLUNTEERS:

        Good general health. No significant hematologic, renal, hepatic, endocrinologic, or
        pulmonary disorders.

        No evidence of HIV infection by standard HIV antibody testing.

        Body mass index for age below 85th percentile.

        Not currently using prescription medications on a continuing basis; the use of
        over-the-counter medications will be reviewed on a case-by-case basis.

        Stable clinical condition during evaluation.

        CHILDREN WITH CONDITIONS CAUSING CHRONIC INFECTIONS OTHER THAN HIV:

        Evidence of chronic, non-HIV-related infection such as chronic granulomatous disease,
        hyperimmunoglobin E syndrome, etc.

        Evidence of non-growth hormone-deficient growth failure, defined as a 12-month height
        velocity at or below the fifth percentile for age using standard reference norms and by
        clinically-indicated testing.

        No evidence of HIV infection by standard HIV antibody testing.

        No current (last 2 months) use of sex steroid supplementation.

        Enrollment in an ongoing NIH protocol for treatment of their disorders.

        Age between 4 and 18 years.

        No other chronic disease unrelated to infection that may cause either changes in body
        composition or lipid or glucose homeostasis such as Type I diabetes mellitus,
        lipodystrophic diabetes, Cushing's syndrome etc.

        No pregnancy.

        No inability to undergo MRI because of metal objects within their bodies that are
        contraindications for MRI. These include cardiac pacemakers, neural pacemakers, aneurysmal
        clips, schrapnel, ocular foreign bodies, cochlear implants, non-detachable electronic or
        electromechanical devices.

        No allergic reaction to heparin.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00001142

Organization ID

000010

Secondary IDs

00-CH-0010


Study Sponsor

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


Study Sponsor

, , 


Verification Date

October 2000