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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000852 |
To examine, in HIV-infected patients, the safety of allogeneic lymphocyte transfer (i.e., 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.
Condition | Intervention |
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HIV Infections |
Procedure: Allogeneic lymphocyte transfer |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection |
Estimated Enrollment: | 12 |
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, 2.5 years, and 3 years).
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Required:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Donors with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Prior Treatment:
Excluded:
Required:
Active substance abuse.
United States, Ohio | |
Univ Hosp of Cleveland / Case Western Reserve Univ | |
Cleveland, Ohio, United States, 44106 |
Study Chair: | Lederman M | |
Study Chair: | Lee E | |
Study Chair: | Deyton L |
Study ID Numbers: | DATRI 016 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000852 |
Health Authority: | United States: Federal Government |
T-Lymphocytes Acquired Immunodeficiency Syndrome Transplantation, Homologous Immunotherapy, Adoptive |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Communicable Diseases RNA Virus Infections Slow Virus Diseases |
Immune System Diseases Lentivirus Infections Infection |