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CompletedNCT00000852Updated Jun 24, 2005

A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection

An interventional study of Allogeneic lymphocyte transfer in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
12
Ages
18 Years to 50 Years
Sex
All
01

Study 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 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.

Read the 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).

02

Conditions studied

  • HIV Infections

Keywords

  • T-Lymphocytes
  • Acquired Immunodeficiency Syndrome
  • Transplantation, Homologous
  • Immunotherapy, Adoptive
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 12 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.

Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Enrollment
12 participants

Interventions

  • ProcedureAllogeneic lymphocyte transfer
06

Study locations

1 site
  • Univ Hosp of Cleveland / Case Western Reserve Univ
    Cleveland, Ohio 44106, United States
07

References and documents

Publications

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00000852
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
First posted
Aug 31, 2001
Last update
Jun 24, 2005

Study contacts

Lederman M
study chair
Lee E
study chair
Deyton L
study chair
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 1998. You cannot join it, but the record below documents what was studied.

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