Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000756
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
Evaluation of the Safety and Tolerance of Immunotherapy With Autologous Ex-Vivo Expanded HIV-Specific Cytotoxic T-Cells in HIV-Infected Patients With CD4 Counts Between 100-400mm3
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Evaluation of the Safety and Tolerance of Immunotherapy With Autologous Ex-Vivo Expanded HIV-Specific Cytotoxic T-Cells in HIV-Infected Patients With CD4 Counts Between 100-400mm3
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:
To determine the safety tolerance and feasibility of adoptive immunotherapy with autologous cytotoxic T-lymphocytes CTLs in HIV-infected patients with CD4 counts between 100 and 400 to evaluate the immunologic virologic and clinical changes for up to 24 weeks following infusion of study therapy
Freshly isolated peripheral blood lymphocytes from HIV-1-seropositive individuals frequently lyse autologous HIV-1-expressing cells or autologous cells infected with vaccinia vectors encoding HIV-1-specific proteins Administration of these cytotoxic T lymphocytes CTLs may help prevent HIV disease progression
Freshly isolated peripheral blood lymphocytes from HIV-1-seropositive individuals frequently lyse autologous HIV-1-expressing cells or autologous cells infected with vaccinia vectors encoding HIV-1-specific proteins Administration of these cytotoxic T lymphocytes CTLs may help prevent HIV disease progression
Detailed Description:
Freshly isolated peripheral blood lymphocytes from HIV-1-seropositive individuals frequently lyse autologous HIV-1-expressing cells or autologous cells infected with vaccinia vectors encoding HIV-1-specific proteins Administration of these cytotoxic T lymphocytes CTLs may help prevent HIV disease progression
AMENDED 032894
Patients are not accrued at the 25 billion CTL dose Instead a third cohort receives three infusions of 1 billion CTL 5-8 weeks apart
AMENDED 021494
Patients infused with 1 or 5 billion CTL will be reinfused with 1 billion CTL 6-12 months later and then followed for up to 12 weeks after the reinfusion
ORIGINAL DESIGN
Fifteen patients whose cells show an HIV-specific cytotoxic T lymphocyte CTL response are infused with autologous ex-vivo expanded CTLs at a dose of 1 5 or 25 billion cells five patients per dose level If one to three patients at a given dose develop acute toxicity an additional three patients will be entered at that dose If four patients at any given dose develop acute toxicity the next lower dose will be designated as the MTD if four patients develop acute toxicity in the first cohort the study will be terminated Patients are evaluated during infusion and at 1 2 4 8 and 24 weeks
AMENDED 032894
Patients are not accrued at the 25 billion CTL dose Instead a third cohort receives three infusions of 1 billion CTL 5-8 weeks apart
AMENDED 021494
Patients infused with 1 or 5 billion CTL will be reinfused with 1 billion CTL 6-12 months later and then followed for up to 12 weeks after the reinfusion
ORIGINAL DESIGN
Fifteen patients whose cells show an HIV-specific cytotoxic T lymphocyte CTL response are infused with autologous ex-vivo expanded CTLs at a dose of 1 5 or 25 billion cells five patients per dose level If one to three patients at a given dose develop acute toxicity an additional three patients will be entered at that dose If four patients at any given dose develop acute toxicity the next lower dose will be designated as the MTD if four patients develop acute toxicity in the first cohort the study will be terminated Patients are evaluated during infusion and at 1 2 4 8 and 24 weeks
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11736 | REGISTRY | DAIDS ES Registry Number | None |