Growth Hormone Treatment of Children With HIV-Associated Growth Failure
A Randomized, Open-Label Study of Recombinant Human Growth Hormone (r-hGH) in Children With HIV-Associated Growth Failure
4 other identifiers
interventional
102
2 countries
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv-infections
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2002
CompletedNovember 1, 2021
October 1, 2021
August 7, 2000
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Phoenix Children's Hosp.
Phoenix, Arizona, 85006, United States
Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
Los Angeles, California, 900276016, United States
UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California, 92103, United States
South Florida CDC Ft Lauderdale NICHD CRS
Fort Lauderdale, Florida, 33311, United States
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, 32209, 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, 30306, United States
Chicago Children's CRS
Chicago, Illinois, 606143394, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, 01199, United States
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, 10037, United States
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, 13210, United States
Jacobi Med. Ctr. Bronx NICHD CRS
The Bronx, New York, 10457, United States
Jacobi Med. Ctr.
The Bronx, New York, 10461, United States
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, United States
DUMC Ped. CRS
Durham, North Carolina, 277103499, 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, 00956, Puerto Rico
San Juan City Hosp. PR NICHD CRS
San Juan, 009367344, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Harland Winter
- STUDY CHAIR
Wayne Dankner