Growth Hormone Treatment of Children With HIV-Associated Growth Failure

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00006143

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

102

Enrollment

Locations

5.1

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Somatropin	N/A

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.]

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

A Randomized, Open-Label Study of Recombinant Human Growth Hormone (r-hGH) in Children With HIV-Associated Growth Failure

Actual Study Completion Date :

Jul 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 13 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Phoenix Children's Hosp.	Phoenix	Arizona	United States	85006
2	Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy	Los Angeles	California	United States	900276016
3	UCSD Maternal, Child, and Adolescent HIV CRS	San Diego	California	United States	92103
4	South Florida CDC Ft Lauderdale NICHD CRS	Fort Lauderdale	Florida	United States	33311
5	Univ. of Florida Jacksonville NICHD CRS	Jacksonville	Florida	United States	32209
6	Univ. of Miami Ped. Perinatal HIV/AIDS CRS	Miami	Florida	United States
7	Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases	Atlanta	Georgia	United States	30306
8	Chicago Children's CRS	Chicago	Illinois	United States	606143394
9	HMS - Children's Hosp. Boston, Div. of Infectious Diseases	Boston	Massachusetts	United States
10	Baystate Health, Baystate Med. Ctr.	Springfield	Massachusetts	United States	01199
11	Jacobi Med. Ctr. Bronx NICHD CRS	Bronx	New York	United States	10457
12	Jacobi Med. Ctr.	Bronx	New York	United States	10461
13	Bronx-Lebanon Hosp. IMPAACT CRS	Bronx	New York	United States
14	Harlem Hosp. Ctr. NY NICHD CRS	New York	New York	United States	10037
15	SUNY Upstate Med. Univ., Dept. of Peds.	Syracuse	New York	United States	13210
16	DUMC Ped. CRS	Durham	North Carolina	United States	277103499
17	Texas Children's Hosp. CRS	Houston	Texas	United States
18	VCU Health Systems, Dept. of Peds	Richmond	Virginia	United States
19	Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.	Bayamon		Puerto Rico	00956
20	San Juan City Hosp. PR NICHD CRS	San Juan		Puerto Rico	009367344