Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000680
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
1999-11-02
Brief Title:
A Phase I Study of Autologous Activated CD8 Lymphocytes Expanded In Vitro and Infused With or Without Recombinant Interleukin-2 to Patients With AIDS or Severe ARC
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Study of Autologous Activated CD8 Lymphocytes Expanded In Vitro and Infused With or Without Recombinant Interleukin-2 to Patients With AIDS or Severe ARC
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:
1 To determine whether it is possible to remove and culture increase in number and activate in the laboratory CD8 lymphocytes white blood cells from HIV-infected patients receiving zidovudine AZT 2 To determine the toxicity of returning to the patients intravenously the expanded and activated autologous cells given to the patient from whom they were taken with and without giving the patients recombinant interleukin-2 aldesleukin IL-2 at the same time 3 To radiolabel mark the CD8 lymphocytes with Indium 111 and then scan the patients to determine the distribution of the CD8 lymphocytes in those who are and are not given IL-2 infusions 4 To determine the toxicity of IL-2 given at the same time with autologous CD8 lymphocytes 5 To measure changes in the immunology of the subjects following these treatments
CD8 cells are suppressorkiller lymphocyte cells that act to limit replication of viruses It is hoped that the reinfusion of activated autologous CD8 cells into patients with AIDS will help to control opportunistic infections such as cytomegalovirus and toxoplasmosis two of the leading causes of sickness and death in AIDS patients This treatment may also stop the HIV virus from replicating reproducing itself in the AIDS patient Further activation of these cells once infused may be necessary It is hoped that IL-2 will stimulate the patients immune system against the AIDS virus along with the activated CD8 cells Thus IL-2 will be given and its effects studied
CD8 cells are suppressorkiller lymphocyte cells that act to limit replication of viruses It is hoped that the reinfusion of activated autologous CD8 cells into patients with AIDS will help to control opportunistic infections such as cytomegalovirus and toxoplasmosis two of the leading causes of sickness and death in AIDS patients This treatment may also stop the HIV virus from replicating reproducing itself in the AIDS patient Further activation of these cells once infused may be necessary It is hoped that IL-2 will stimulate the patients immune system against the AIDS virus along with the activated CD8 cells Thus IL-2 will be given and its effects studied
Detailed Description:
CD8 cells are suppressorkiller lymphocyte cells that act to limit replication of viruses It is hoped that the reinfusion of activated autologous CD8 cells into patients with AIDS will help to control opportunistic infections such as cytomegalovirus and toxoplasmosis two of the leading causes of sickness and death in AIDS patients This treatment may also stop the HIV virus from replicating reproducing itself in the AIDS patient Further activation of these cells once infused may be necessary It is hoped that IL-2 will stimulate the patients immune system against the AIDS virus along with the activated CD8 cells Thus IL-2 will be given and its effects studied
AMENDED 092890 The CD8 lymphocytes are grown in vitro for 21 days before infusion Leukapheresis and infusion continue every 21 days for 3 infusions with the last infusion during week 16 During weeks 13 and 16 indium 111 radio labelled cells are injected to permit determination of the distribution and pharmacokinetics of the infused cells At week 16 IL-2 is administered concurrently with Indium 111 labelled cells and the CD8 lymphocytes - delivered by continuous infusion over 5 days following cell infusion Patients are followed at the clinic 1 week prior to scheduled infusions during infusion weeks and then every 2 weeks to week 21 and at week 27 Original design Patients undergo leukapheresis every 2 weeks for a total of 6 times during the initial phase of the study During this procedure a catheter is placed in an arm vein and the blood flows through a machine which separates the lymphocytes from the other blood components The blood is then returned to the patients body through the catheter Less than 10 percent of the lymphocytes in the blood are removed during the process The CD8 cells taken from the patient are cultured in the laboratory until they increase 10- to 1000-fold These cells are then infused back into the patient from whom they were taken The first two patients are admitted for 24 hours at the time of each infusion In the absence of severe side effects the subsequent four patients are infused at the clinic Patients are admitted for 5 days for continuous infusion of IL-2 in week 13
AMENDED 092890 The CD8 lymphocytes are grown in vitro for 21 days before infusion Leukapheresis and infusion continue every 21 days for 3 infusions with the last infusion during week 16 During weeks 13 and 16 indium 111 radio labelled cells are injected to permit determination of the distribution and pharmacokinetics of the infused cells At week 16 IL-2 is administered concurrently with Indium 111 labelled cells and the CD8 lymphocytes - delivered by continuous infusion over 5 days following cell infusion Patients are followed at the clinic 1 week prior to scheduled infusions during infusion weeks and then every 2 weeks to week 21 and at week 27 Original design Patients undergo leukapheresis every 2 weeks for a total of 6 times during the initial phase of the study During this procedure a catheter is placed in an arm vein and the blood flows through a machine which separates the lymphocytes from the other blood components The blood is then returned to the patients body through the catheter Less than 10 percent of the lymphocytes in the blood are removed during the process The CD8 cells taken from the patient are cultured in the laboratory until they increase 10- to 1000-fold These cells are then infused back into the patient from whom they were taken The first two patients are admitted for 24 hours at the time of each infusion In the absence of severe side effects the subsequent four patients are infused at the clinic Patients are admitted for 5 days for continuous infusion of IL-2 in week 13
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 |
|---|---|---|---|
| 11055 | REGISTRY | DAIDS ES Registry Number | None |