A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Allogeneic lymphocyte transfer

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring T-Lymphocytes, Acquired Immunodeficiency Syndrome, Transplantation, Homologous, Immunotherapy, Adoptive

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Univ Hosp of Cleveland / Case Western Reserve Univ

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00000852

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

1. Study Identification

Unique Protocol Identification Number

NCT00000852

Brief Title

A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection

Official Title

A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection

Study Type

Interventional

2. Study Status

Record Verification Date

November 1998

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Enrollment

12 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Allogeneic lymphocyte transfer

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

No

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lederman M

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Lee E

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Deyton L

Official's Role

Study Chair

Facility Information:

Facility Name

Univ Hosp of Cleveland / Case Western Reserve Univ

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

11363923

Citation

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

Results Reference

background

HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial