Growth Hormone Treatment of Children With HIV-Associated Growth Failure
Condition: HIV Infections
MeSH terms: HIV Infections; Failure to Thrive
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effectiveness of recombinant human growth
      hormone (r-hGH) on growth in HIV-infected children.

      Studies have shown that HIV-infected children do not grow at a normal rate and are shorter
      than HIV-uninfected children who are the same age. Growth hormone has been used for many
      years to treat children with growth hormone deficiency and has been safe and effective in
      helping them to grow normally. The growth hormone to be used in this study, r-hGH, is an
      investigational hormone (not yet approved by the Food and Drug Administration [FDA]) made in
      the laboratory. It has helped HIV-positive adults gain weight and improve their physical
      performance. This study has been changed to include a needle-free device for drug delivery
      which will improve patient comfort and acceptability. Patients will no longer receive growth
      hormone through traditional needles but through a needle-free device.
    

Detailed description: 
      Wasting, or loss of lean tissue, is a serious consequence of AIDS. Body composition findings
      in HIV-infected children are similar to those of HIV-uninfected children with classic growth
      hormone deficiency. Evidence suggests that therapeutic administration of growth hormone (GH)
      can induce anabolic effects, reverse pathologic catabolism, and perhaps even improve immune
      function. As survival to adolescence and beyond improves with modern therapy in children with
      HIV infection, it will become increasingly important to address the problems of stunting and
      short stature in this population. [AS PER AMENDMENT 09/04/01: Recent evidence suggests that
      needle-free delivery is preferred by young children below the age of ten years. Given the
      advantages of a needle-free delivery system for the administration of growth hormone, most
      significantly the reduction of risk for HIV contaminated needle-stick injuries to care
      providers and other household members, it has been decided to use this method of study drug
      delivery for all study participants.]

      Children are assigned randomly to 1 of the following treatment groups:

      Group 1: Children receive a single dose of r-hGH once a day. Group 2: Children receive half
      the dose of r-hGH that Group 1 receives, once a day.

      Group 3a: Children receive no r-hGH for the first 24 weeks [AS PER AMENDMENT 01/03/01: 48
      weeks] of the study. After Week 24 [AS PER AMENDMENT 01/03/01: Week 48], they receive the
      same dose as that of Group 1.

      Group 3b: Children receive no r-hGH for the first 24 weeks [AS PER AMENDMENT 01/03/01: 48
      weeks] of the study. After Week 24 [AS PER AMENDMENT 01/03/01: Week 48], they receive the
      same dose as that of Group 2.

      Subcutaneous injections are administered [AS PER AMENDMENT 09/04/01: using a needle-free
      device], daily for 96 weeks in Groups 1 and 2; after 24 weeks [AS PER AMENDMENT 01/03/01: 48
      weeks] on study, the treatment-delayed control group (Group 3) receives injections for 72
      weeks [AS PER AMENDMENT 01/03/01: 48 weeks]. The first injection is at the clinic and
      parents/guardians are trained how to prepare and administer the injections. Children are
      closely monitored for toxicity, with dosing adjustments if needed. Evaluations and laboratory
      tests are done at clinic visits every 4 weeks to determine growth indicators, body
      chemistries, CD4 cell counts, HIV-1 RNA PCR, and anti-hGH antibodies and for routine
      hematology testing, dietary intake assessment, and MRI scans. [AS PER AMENDMENT 01/03/01: MRI
      scans are no longer performed.]
    

Intervention name(s): Somatropin
Intervention type(s): Drug
Primary purpose: Treatment
Keywords: Treatment Outcome; serostim; Developmental Disabilities