Growth Hormone Treatment of Children With HIV-Associated Growth Failure
Status:
Completed
Trial end date:
2002-07-01
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)