Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000824
Status:
TERMINATED
Last Update Posted:
2016-12-14
First Post:
1999-11-02
Brief Title:
A Study of Cytotoxic T Lymphocyte CTL Therapy in HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Pilot Study of HIV Specific Cytotoxic T Lymphocyte CTL Therapy in HIV-Infected Patients With CD4 T Cells 100-350 Cellsmm3
Status:
TERMINATED
Status Verified Date:
1995-04
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:
To define the safety of cytotoxic T lymphocytes CTLs generated from sibling-supplied dendritic cells and lymphocytes and infused into an HIV-infected patient To determine the efficacy of these CTLs in helping the immune system to fight HIV
With lower CD4 counts HIV-infected patients may not be able to produce dendritic cells and lymphocytes special types of immune cells that generate HIV-specific CTLs Infusion of CTLs generated from the dendritic cells and lymphocytes of an HIV-negative sibling may enable the body to recognize HIV more readily and increase immune response against the virus
With lower CD4 counts HIV-infected patients may not be able to produce dendritic cells and lymphocytes special types of immune cells that generate HIV-specific CTLs Infusion of CTLs generated from the dendritic cells and lymphocytes of an HIV-negative sibling may enable the body to recognize HIV more readily and increase immune response against the virus
Detailed Description:
With lower CD4 counts HIV-infected patients may not be able to produce dendritic cells and lymphocytes special types of immune cells that generate HIV-specific CTLs Infusion of CTLs generated from the dendritic cells and lymphocytes of an HIV-negative sibling may enable the body to recognize HIV more readily and increase immune response against the virus
Dendritic cells and lymphocytes are obtained from an HIV-negative sibling HIV-specific CTLs are generated from these cells and then infused into the HIV-infected patient monthly for 6 months Siblings must be able to donate on multiple occasions and patients are followed every 2-4 weeks during the study Patients are screened over 3 months prior to study entry
Dendritic cells and lymphocytes are obtained from an HIV-negative sibling HIV-specific CTLs are generated from these cells and then infused into the HIV-infected patient monthly for 6 months Siblings must be able to donate on multiple occasions and patients are followed every 2-4 weeks during the study Patients are screened over 3 months prior to study entry
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: