A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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 ...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Required:
• • Stable antiretroviral therapy.
• Allowed:
• • Maintenance therapy for a controlled opportunistic infection.
• Patients must have:
• • HIV infection.
• • CD4 count 50-200 cells/mm3.
• • No ongoing major opportunistic infections.
• • Been on stable antiretroviral therapy for the past 2 months.
• • Tonsils present.
• • Life expectancy greater than 6 months.
• • An HLA-single haplotype matched, single haplotype mismatched parent, sibling, or adult offspring who is ABO, Rh compatible to serve as an HIV-negative lymphocyte donor.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Lymphoma or other malignancy requiring chemotherapy.
• • Bleeding disorder that would preclude a tonsillar biopsy.
• • Antibody on donor/recipient lymphocyte reactive antibody assay.
• Donors with the following symptoms or conditions are excluded:
• • Medical condition that would endanger health of donor or recipient.
• • Failure to meet established donor standards on blood screening tests.
• • CMV seropositivity if the patient (recipient) is CMV seronegative.
• • Pregnancy.
• Concurrent Medication:
• Excluded:
• • GM-CSF or G-CSF.
• • Any investigational drug.
• • Immunomodulators (such as interferon, steroids, topical corticosteroids, thalidomide, pentoxifylline, IL-2).
• • Nonsteroidal anti-inflammatory drugs.
• • Aspirin.
• Prior Treatment:
• Excluded:
• • Blood transfusion within the past 2 months.
• Required:
• • Stable antiretroviral therapy for at least 2 months prior to study entry.
• • Active substance abuse.