A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection

June 23, 2005 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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).

Study Type

Interventional

Enrollment

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Univ Hosp of Cleveland / Case Western Reserve Univ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Lee E
  • Study Chair: Deyton L

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

November 1, 1998

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DATRI 016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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