Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001647
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
White Blood Cell Infusions to Treat HIV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Effects of Repeated Infusions of Adoptively Transferred Syngeneic Lymphocytes on the Immune Systems of HIV-1 Infected Identical Twins
Status:
COMPLETED
Status Verified Date:
2002-08
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 will evaluate the safety and immune system effects of infusing HIV-infected patients with multiple doses of lymphocytes white blood cells from their non-infected identical twin It will determine whether the donated lymphocytes can improve immune function and reduce viral load in the infected twin
Identical twin pairs-one who is infected with HIV-1 and one who is negative for the virus-may be eligible for this study Candidates will be screened with blood tests a medical history and physical examination
Both twin participants will receive a tetanus booster shot if needed The non-infected twin will undergo apheresis to collect white blood cells For this procedure whole blood is collected similar to the procedure for donating a unit of blood from a needle in the arm The blood flows through a cell separator machine where the white cells are removed and the rest of the blood red cells plasma and platelets is returned to the donor through a catheter in the opposite arm
The collected lymphocytes will be given intravenously through a vein to the infected twin over a 60-minute period This procedure-apheresis and infusions-will be repeated 4 days a week to complete one cycle The cycles will be repeated about every 8 weeks for 6 cycles about 1 year
The infected twin will have blood samples drawn on the first day of each cycle 2 weeks after the beginning of each cycle and 4 weeks after each cycle to evaluate immune status viral load and other safety parameters The frequency of these blood tests may change as the study progresses The infected twin will also undergo apheresis immediately before each cycle of infusions and one month later to test the white cells for certain immune features The number of apheresis procedures may be reduced as the study proceeds
Identical twin pairs-one who is infected with HIV-1 and one who is negative for the virus-may be eligible for this study Candidates will be screened with blood tests a medical history and physical examination
Both twin participants will receive a tetanus booster shot if needed The non-infected twin will undergo apheresis to collect white blood cells For this procedure whole blood is collected similar to the procedure for donating a unit of blood from a needle in the arm The blood flows through a cell separator machine where the white cells are removed and the rest of the blood red cells plasma and platelets is returned to the donor through a catheter in the opposite arm
The collected lymphocytes will be given intravenously through a vein to the infected twin over a 60-minute period This procedure-apheresis and infusions-will be repeated 4 days a week to complete one cycle The cycles will be repeated about every 8 weeks for 6 cycles about 1 year
The infected twin will have blood samples drawn on the first day of each cycle 2 weeks after the beginning of each cycle and 4 weeks after each cycle to evaluate immune status viral load and other safety parameters The frequency of these blood tests may change as the study progresses The infected twin will also undergo apheresis immediately before each cycle of infusions and one month later to test the white cells for certain immune features The number of apheresis procedures may be reduced as the study proceeds
Detailed Description:
This phase III study will evaluate the safety immunologic effects and potential efficacy of repeated infusions of syngeneic lymphocytes obtained from HIV-1 seronegative identical twins given in the setting of maximum anti-retroviral therapy Unfractionated lymphocytes from each seronegative twin will be obtained by lymphocytapheresis and directly transferred to the HIV-1 seropositive twin Four separate lymphocytaphereses and transfers will be performed over one week and this cycle may be repeated as frequently as every 8 weeks for a total of up to 6 cycles The recipient twin will be monitored for general health status immunologic improvement depletions within the CD4 T-cell repertoire and HIV-1 viral load
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 |
|---|---|---|---|
| 97-I-0165 | None | None | None |