Clinical trial NCT00006143: Growth Hormone Treatment of Children With HIV-Associated Growth Failure
Official title: A Randomized, Open-Label Study of Recombinant Human Growth Hormone (r-hGH) in Children With HIV-Associated Growth Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Treatment Outcome
serostim
Developmental Disabilities
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2001-08-31
Enrollment: 102
Sex: ALL
Minimum age (years): 4
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hosp.
state: Arizona
city: Los Angeles
country: United States
facility: Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
state: California
city: San Diego
country: United States
facility: UCSD Maternal, Child, and Adolescent HIV CRS
state: California
city: Fort Lauderdale
country: United States
facility: South Florida CDC Ft Lauderdale NICHD CRS
state: Florida
city: Jacksonville
country: United States
facility: Univ. of Florida Jacksonville NICHD CRS
state: Florida
city: Miami
country: United States
facility: Univ. of Miami Ped. Perinatal HIV/AIDS CRS
state: Florida
city: Atlanta
country: United States
facility: Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
state: Georgia
city: Chicago
country: United States
facility: Chicago Children's CRS
state: Illinois
city: Boston
country: United States
facility: HMS - Children's Hosp. Boston, Div. of Infectious Diseases
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Health, Baystate Med. Ctr.
state: Massachusetts
city: Bronx
country: United States
facility: Jacobi Med. Ctr. Bronx NICHD CRS
state: New York
city: Bronx
country: United States
facility: Jacobi Med. Ctr.
state: New York
city: Bronx
country: United States
facility: Bronx-Lebanon Hosp. IMPAACT CRS
state: New York
city: New York
country: United States
facility: Harlem Hosp. Ctr. NY NICHD CRS
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Med. Univ., Dept. of Peds.
state: New York
city: Durham
country: United States
facility: DUMC Ped. CRS
state: North Carolina
city: Houston
country: United States
facility: Texas Children's Hosp. CRS
state: Texas
city: Richmond
country: United States
facility: VCU Health Systems, Dept. of Peds
state: Virginia
city: Bayamon
country: Puerto Rico
facility: Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
city: San Juan
country: Puerto Rico
facility: San Juan City Hosp. PR NICHD CRS
Study officials:
name: Harland Winter
role: STUDY_CHAIR
name: Wayne Dankner
role: STUDY_CHAIR
References: