A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection

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.