HIV InfectionsNCT00006143
Growth Hormone Treatment of Children With HIV-Associated Growth Failure
A study testing Somatropin in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 20 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 13 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Somatropin
- How many people
- 102 participants
- Where
- 20 sitesin 2 countries
- Study dates
- Start not givento Jul 2002
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United States18 sites
Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
Atlanta, Georgia, 30306
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts
Chicago Children's CRS
Chicago, Illinois, 606143394
DUMC Ped. CRS
Durham, North Carolina, 277103499
South Florida CDC Ft Lauderdale NICHD CRS
Fort Lauderdale, Florida, 33311
Texas Children's Hosp. CRS
Houston, Texas
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, 32209
Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
Los Angeles, California, 900276016
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, 10037
Phoenix Children's Hosp.
Phoenix, Arizona, 85006
VCU Health Systems, Dept. of Peds
Richmond, Virginia
UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California, 92103
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, 01199
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, 13210
Jacobi Med. Ctr. Bronx NICHD CRS
The Bronx, New York, 10457
Jacobi Med. Ctr.
The Bronx, New York, 10461
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York
Puerto Rico2 sites
Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
Bayamón, 00956
San Juan City Hosp. PR NICHD CRS
San Juan, 009367344
About this study
Official title: 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.
Read the 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.]
- Conditions
- HIV Infections
- Being tested
- Somatropin
- Keywords
- Treatment Outcome, serostim, Developmental Disabilities
- Medical subject headings
- HIV Infections, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatropinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionJul 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Enrolment
- 102 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Harland Winter, Study chairWayne Dankner, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006143
- Sponsor's protocol ID
- P1011
- Other IDs
- 11646, ACTG P1011, PACTG P1011
- Status last verified
- Oct 2021
- First submitted
- 7 Aug 2000
- Last updated
- 1 Nov 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label Study of Recombinant Human Growth Hormone (r-hGH) in Children With HIV-Associated Growth Failure
- ClinicalTrials.gov ID
- NCT00006143
- Acronym / sponsor ID
- P1011
- Conditions
- HIV Infections
- Keywords
- Treatment Outcome, serostim, Developmental Disabilities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study completion
- Jul 2002 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.]
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Somatropin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harland Winter study chair
Wayne Dankner study chair
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Somatropin in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 20 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.