Status:
COMPLETED
A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
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 compati...
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 t...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00000852
Last Update
June 24 2005
Active Locations (1)
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1
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, United States, 44106