Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006143
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2000-08-07
Brief Title:
Growth Hormone Treatment of Children With HIV-Associated Growth Failure
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Open-Label Study of Recombinant Human Growth Hormone r-hGH in Children With HIV-Associated Growth Failure
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 090401 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 010301 48 weeks of the study After Week 24 AS PER AMENDMENT 010301 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 010301 48 weeks of the study After Week 24 AS PER AMENDMENT 010301 Week 48 they receive the same dose as that of Group 2
Subcutaneous injections are administered AS PER AMENDMENT 090401 using a needle-free device daily for 96 weeks in Groups 1 and 2 after 24 weeks AS PER AMENDMENT 010301 48 weeks on study the treatment-delayed control group Group 3 receives injections for 72 weeks AS PER AMENDMENT 010301 48 weeks The first injection is at the clinic and parentsguardians 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 010301 MRI scans are no longer performed
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 010301 48 weeks of the study After Week 24 AS PER AMENDMENT 010301 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 010301 48 weeks of the study After Week 24 AS PER AMENDMENT 010301 Week 48 they receive the same dose as that of Group 2
Subcutaneous injections are administered AS PER AMENDMENT 090401 using a needle-free device daily for 96 weeks in Groups 1 and 2 after 24 weeks AS PER AMENDMENT 010301 48 weeks on study the treatment-delayed control group Group 3 receives injections for 72 weeks AS PER AMENDMENT 010301 48 weeks The first injection is at the clinic and parentsguardians 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 010301 MRI scans are no longer performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PACTG P1011 | Registry Identifier | DAIDS ES | None |
| 11646 | REGISTRY | None | None |
| ACTG P1011 | None | None | None |