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