Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000852
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection
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 Allogeneic Lymphocyte Transfer in HIV Infection
Status:
COMPLETED
Status Verified Date:
1998-11
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 examine in HIV-infected patients the safety of allogeneic lymphocyte transfer ie infusion of white blood cells taken from an HIV-negative parent sibling or adult offspring who has a compatible blood type To measure the distribution and survival of allogeneic lymphocytes in the circulation of HIV-infected patients and to determine whether their infusion results in enhanced immunity To determine whether enhanced immunity is passively transferred or actively induced
There is evidence that periodic infusion of allogeneic lymphocytes obtained from the peripheral blood of HLA-matched HIV-1 seronegative siblings of patients with AIDS can in some instances restore the number of circulating CD4 lymphocytes However more controlled studies are needed to better quantitate the immunologic reconstitution seen with this type of therapy
There is evidence that periodic infusion of allogeneic lymphocytes obtained from the peripheral blood of HLA-matched HIV-1 seronegative siblings of patients with AIDS can in some instances restore the number of circulating CD4 lymphocytes However more controlled studies are needed to better quantitate the immunologic reconstitution seen with this type of therapy
Detailed Description:
There is evidence that periodic infusion of allogeneic lymphocytes obtained from the peripheral blood of HLA-matched HIV-1 seronegative siblings of patients with AIDS can in some instances restore the number of circulating CD4 lymphocytes However more controlled studies are needed to better quantitate the immunologic reconstitution seen with this type of therapy
Lymphocytes obtained by leukapheresis from a healthy HIV-negative parent sibling or adult offspring of the HIV-infected patient are infused at day 0 and at weeks 4 and 8 A small portion of the lymphocytes obtained at day 0 will be radiolabeled prior to infusion and two total body scans will be performed Patients also undergo two tonsillar biopsies Patients are followed weekly for 16 weeks then by telephone periodically for 3 years at 1 year 2 years 25 years and 3 years
Lymphocytes obtained by leukapheresis from a healthy HIV-negative parent sibling or adult offspring of the HIV-infected patient are infused at day 0 and at weeks 4 and 8 A small portion of the lymphocytes obtained at day 0 will be radiolabeled prior to infusion and two total body scans will be performed Patients also undergo two tonsillar biopsies Patients are followed weekly for 16 weeks then by telephone periodically for 3 years at 1 year 2 years 25 years and 3 years
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?: