A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection

NCT00000852 | Completed

• 1 other identifier: DATRI 016
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 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

HIV Infections

Keywords

T-Lymphocytes; Acquired Immunodeficiency Syndrome; Transplantation, Homologous; Immunotherapy, Adoptive

Interventions

Allogeneic lymphocyte transfer PROCEDURE

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Univ Hosp of Cleveland / Case Western Reserve Univ

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• Volunteers sought for HIV treatment study. NIAID AIDS Agenda. 1996 Sep:3.

  PMID: 11363923 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Officials

• Lederman M

  STUDY CHAIR

• Lee E

  STUDY CHAIR

• Deyton L

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1998-11

Locations

US (1)