Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050921
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2002-12-30
Brief Title:
Administration of Growth Hormone to Increase CD4 Count in Patients Taking Anti-HIV Drugs
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Improving Immune Reconstitution With Growth Hormone in HIV-infected Subjects With Incomplete CD4 Lymphocyte Restoration on Highly Active Antiretroviral Therapy HAART
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:
This study is designed to evaluate the ability of growth hormone GH also known as somatropin to increase CD4 cell counts in patients taking anti-HIV drugs The study is targeted toward patients with low levels of HIV who continue to have low CD4 cell counts
Detailed Description:
After initiation of HAART many HIV infected patients have significant improvement in CD4 levels However some patients continue to have low CD4 counts 350 cellsmm3 despite adequate viral suppression The purpose of this study is to determine whether administration of GH will increase naïve CD4 production Further the study will assess whether an increase in naïve CD4 production will lead to increases in antigen-specific CD4 and CD8 T cells
Patients enrolled in this study will be randomized to one of two groups Patients in both groups will continue their present HAART regimen for the duration of the study Group A patients will receive daily subcutaneous injections of GH for 48 weeks Group B participants will receive no additional therapy for 24 weeks and will then receive daily subcutaneous GH injections during Weeks 24-28 of the study Both groups will receive immunocyanin keyhole-limpet hemocyanin injections at Weeks 16 and 20 and hepatitis A vaccination at Weeks 40 and 44 At the conclusion of Week 48 all patients will discontinue GH therapy while maintaining their HAART regimen Patients will then be followed for an additional 24 weeks
Patients may be asked to participate in a substudy to measure the size of the thymus in people taking GH Patients in the substudy will have a noncontrast CT scan of the chest before beginning GH therapy and again after 24 weeks of GH therapy
Patients enrolled in this study will be randomized to one of two groups Patients in both groups will continue their present HAART regimen for the duration of the study Group A patients will receive daily subcutaneous injections of GH for 48 weeks Group B participants will receive no additional therapy for 24 weeks and will then receive daily subcutaneous GH injections during Weeks 24-28 of the study Both groups will receive immunocyanin keyhole-limpet hemocyanin injections at Weeks 16 and 20 and hepatitis A vaccination at Weeks 40 and 44 At the conclusion of Week 48 all patients will discontinue GH therapy while maintaining their HAART regimen Patients will then be followed for an additional 24 weeks
Patients may be asked to participate in a substudy to measure the size of the thymus in people taking GH Patients in the substudy will have a noncontrast CT scan of the chest before beginning GH therapy and again after 24 weeks of GH therapy
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 |
|---|---|---|---|
| ACTG A5174 | Registry Identifier | DAIDS ES Registry Number | None |
| ACTG A5198s | None | None | None |
| 10092 | REGISTRY | None | None |