Growth Hormone Treatment of Children With HIV-Associated Growth Failure

• Status: Completed
• Trial end date: 2002-07-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Hormones

Criteria

Inclusion Criteria

Children may be eligible for this study if they:

• Are 4 to 12 years of age for girls, and 4 to 13 years of age for boys (consent of parent/guardian is required).

• Are HIV-positive.

• Are not growing normally.

• Have a normal intake of food each day.

• Are able to walk.

• Have been on stable anti-HIV therapy for at least 24 weeks before study entry and will continue therapy for the entire duration of the study with no anticipated change in therapy for the first 48 weeks of the study. (These therapy requirements reflect a change.)

• Are willing and able to follow study requirements.

Exclusion Criteria

Children may not be eligible for this study if they:

• Had steady fever of 101 degrees F or higher during the 2 weeks before study entry.

• Have a serious infection requiring medications within 30 days prior to study entry.

• Are being fed through a vein.

• Have severe diarrhea, intestinal bleeding or blockage, or are unable to absorb food.

• Have cancer.

• Have taken medications that may interfere with the study drug or have had radiation.

• Have diabetes or a history of sugar intolerance.

• Have carpal tunnel syndrome (unless it has been surgically repaired).

• Have heart or kidney problems, or serious swelling of any kind.

• Have any condition other than HIV infections that may have affected growth or that makes it difficult to measure height.

• Have any known allergies to the study drug.