Completed

A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection

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What is being tested

Allogeneic lymphocyte transfer

Procedure
Who is being recruted

HIV Infections

From 18 to 50 Years
How is the trial designed

Treatment Study

Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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. 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).

Official TitleA Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
12 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 50 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
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.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Univ Hosp of Cleveland / Case Western Reserve UnivCleveland, United StatesSee the location

CompletedOne Study Center