Completed
Phase Not Applicable
Age: 18Years - 50Years
All Genders
ID00000852
A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2005-06-24
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection
Who Can Participate
Age: 18Years - 50Years
All Genders
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 1 location
1
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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