Growth Hormone Treatment of Children With HIV-Associated Growth Failure

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00006143

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

102

Expected to finish

2002-07-01

Last updated by the study team

2021-11-01

Who can join

Age: 4 and older, up to 13. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Phoenix Children's Hosp. — Phoenix, Arizona, United States
• Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy — Los Angeles, California, United States
• UCSD Maternal, Child, and Adolescent HIV CRS — San Diego, California, United States
• South Florida CDC Ft Lauderdale NICHD CRS — Fort Lauderdale, Florida, United States
• Univ. of Florida Jacksonville NICHD CRS — Jacksonville, Florida, United States
• Univ. of Miami Ped. Perinatal HIV/AIDS CRS — Miami, Florida, United States
• Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases — Atlanta, Georgia, United States
• Chicago Children's CRS — Chicago, Illinois, United States
• HMS - Children's Hosp. Boston, Div. of Infectious Diseases — Boston, Massachusetts, United States
• Baystate Health, Baystate Med. Ctr. — Springfield, Massachusetts, United States
• Harlem Hosp. Ctr. NY NICHD CRS — New York, New York, United States
• SUNY Upstate Med. Univ., Dept. of Peds. — Syracuse, New York, United States
• Jacobi Med. Ctr. Bronx NICHD CRS — The Bronx, New York, United States
• Jacobi Med. Ctr. — The Bronx, New York, United States
• Bronx-Lebanon Hosp. IMPAACT CRS — The Bronx, New York, United States
• DUMC Ped. CRS — Durham, North Carolina, United States
• Texas Children's Hosp. CRS — Houston, Texas, United States
• VCU Health Systems, Dept. of Peds — Richmond, Virginia, United States
• Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds. — Bayamón, Puerto Rico
• San Juan City Hosp. PR NICHD CRS — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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