Growth Hormone Treatment of Children With HIV-Associated Growth Failure

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00006143
First received: August 7, 2000
Last updated: May 17, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
HIV Infections
Drug: Somatropin

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label Study of Recombinant Human Growth Hormone (r-hGH) in Children With HIV-Associated Growth Failure

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 102
Study Completion Date: July 2002
Detailed Description:

Wasting, or loss of lean tissue, is a serious consequence of AIDS. Body composition findings in HIV-infected children are similar to those of HIV-uninfected children with classic growth hormone deficiency. Evidence suggests that therapeutic administration of growth hormone (GH) can induce anabolic effects, reverse pathologic catabolism, and perhaps even improve immune function. As survival to adolescence and beyond improves with modern therapy in children with HIV infection, it will become increasingly important to address the problems of stunting and short stature in this population. [AS PER AMENDMENT 09/04/01: Recent evidence suggests that needle-free delivery is preferred by young children below the age of ten years. Given the advantages of a needle-free delivery system for the administration of growth hormone, most significantly the reduction of risk for HIV contaminated needle-stick injuries to care providers and other household members, it has been decided to use this method of study drug delivery for all study participants.]

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.]

  Eligibility

Ages Eligible for Study:   4 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006143

Locations
United States, Arizona
Phoenix Children's Hosp.
Phoenix, Arizona, United States, 85006
United States, California
Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
Los Angeles, California, United States, 900276016
UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California, United States, 92103
United States, Florida
South Florida CDC Ft Lauderdale NICHD CRS
Fort Lauderdale, Florida, United States, 33311
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States, 32209
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, United States
United States, Georgia
Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
Atlanta, Georgia, United States, 30306
United States, Illinois
Chicago Children's CRS
Chicago, Illinois, United States, 606143394
United States, Massachusetts
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, United States, 01199
United States, New York
Jacobi Med. Ctr.
Bronx, New York, United States, 10461
Jacobi Med. Ctr. Bronx NICHD CRS
Bronx, New York, United States, 10457
Bronx-Lebanon Hosp. IMPAACT CRS
Bronx, New York, United States
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, United States, 10037
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, United States, 13210
United States, North Carolina
DUMC Ped. CRS
Durham, North Carolina, United States, 277103499
United States, Texas
Texas Children's Hosp. CRS
Houston, Texas, United States
United States, Virginia
VCU Health Systems, Dept. of Peds
Richmond, Virginia, United States
Puerto Rico
Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
Bayamon, Puerto Rico, 00956
San Juan City Hosp. PR NICHD CRS
San Juan, Puerto Rico, 009367344
Sponsors and Collaborators
Investigators
Study Chair: Harland Winter
Study Chair: Wayne Dankner
  More Information

Additional Information:
No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00006143     History of Changes
Other Study ID Numbers: P1011, 11646, ACTG P1011, PACTG P1011
Study First Received: August 7, 2000
Last Updated: May 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment Outcome
serostim
Developmental Disabilities

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Failure to Thrive
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Growth Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014