Growth Hormone Treatment of Children With HIV-Associated Growth Failure
NCT ID: NCT00006143
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
102 participants
INTERVENTIONAL
2002-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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. \[AS PER AMENDMENT 01/03/01: MRI scans are no longer performed.\]
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Somatropin
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
4 Years
13 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Harland Winter
Role: STUDY_CHAIR
Wayne Dankner
Role: STUDY_CHAIR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
11646
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG P1011
Identifier Type: -
Identifier Source: secondary_id
PACTG P1011
Identifier Type: -
Identifier Source: secondary_id
P1011
Identifier Type: -
Identifier Source: org_study_id