Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00110578
Status:
COMPLETED
Last Update Posted:
2008-08-08
First Post:
2005-05-10
Brief Title:
Safety and Effectiveness of Immunotherapy With Autologous HIV-Specific CD8 Cells in HIV Infected Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Safety and Antiviral Efficacy of Cellular Adoptive Immunotherapy With Autologous CD8 HIV-Specific Cytotoxic T Cells Combined With Interleukin-2 For HIV Seropositive Individuals
Status:
COMPLETED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Effective suppressive treatment for HIV infected patients can be a major challenge because HIV progressively destroys their immune systems CD8 cells isolated from a patients blood and grown in large numbers in the laboratory may increase a patients immune system response to HIV The purpose of this study is to determine if CD8 cells will provide effective antiviral activity against HIV when transplanted back in large numbers into HIV infected patients
Study hypothesis There are specific cells in the immune system that recognize and can kill HIV-infected cells
Study hypothesis There are specific cells in the immune system that recognize and can kill HIV-infected cells
Detailed Description:
The function of CD8 cells in the human body is to kill infected target cells such as HIV infected cells Recent data suggest that intravenous administration of HIV-specific CD8 cells is safe augments host immunity and mediates a dramatic reduction in circulating HIV-infected CD4 cells However the observed antiviral effects are transient and HIV infected CD4 cells re-emerge as the number of self CD8 cells declines Augmenting CD8 cell response to HIV by immunotherapy with CD8 cells may be a useful addition to drug therapy if the infused CD8 cells can survive long-term in vivo Administration of interleukin-2 also known as aldesleukin or IL-2 a naturally occurring cytokine has been proposed as a way to maintain the number of CD8 cells This study will evaluate the safety and efficacy of immunotherapy with HIV-specific CD8 cells in HIV infected patients Additionally this study will determine if aldesleukin injections improve the persistence of self CD8 transplants and the duration of antiviral activity without severe toxicity
This study will last 18 months CD8 cells will be isolated from the blood of HIV infected patients the cells will be allowed to multiply in the laboratory and patients will receive back their CD8 cells Patients will receive up to 3 infusions of self CD8 cells On Day 0 patients will receive their first infusion of CD8 cells On Day 7 patients will receive their second infusion of CD8 cells this infusion will be followed by 14 days of aldesleukin administered daily by injection under the skin Patients with less than a Grade 2 toxicity will receive a third infusion of CD8 cells this infusion will be followed by 21 days of aldesleukin
This study will last 18 months CD8 cells will be isolated from the blood of HIV infected patients the cells will be allowed to multiply in the laboratory and patients will receive back their CD8 cells Patients will receive up to 3 infusions of self CD8 cells On Day 0 patients will receive their first infusion of CD8 cells On Day 7 patients will receive their second infusion of CD8 cells this infusion will be followed by 14 days of aldesleukin administered daily by injection under the skin Patients with less than a Grade 2 toxicity will receive a third infusion of CD8 cells this infusion will be followed by 21 days of aldesleukin
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 |
|---|---|---|---|
| AI54334 | None | None | None |