Growth Hormone Treatment of Children With HIV-Associated Growth Failure

October 28, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

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

Investigators

  • Study Chair: Wayne Dankner
  • Study Chair: Harland Winter

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

July 1, 2002

Study Registration Dates

First Submitted

August 7, 2000

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

November 1, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P1011
  • 11646 (Registry Identifier: DAIDS ES)
  • ACTG P1011
  • PACTG P1011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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