A Study of Cytotoxic T Lymphocyte (CTL) Therapy in HIV-Infected Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Completion Date

2005-06-30

Brief Summary

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To define the safety of cytotoxic T lymphocytes (CTLs) generated from sibling-supplied dendritic cells and lymphocytes and infused into an HIV-infected patient. To determine the efficacy of these CTLs in helping the immune system to fight HIV.

With lower CD4 counts, HIV-infected patients may not be able to produce dendritic cells and lymphocytes, special types of immune cells that generate HIV-specific CTLs. Infusion of CTLs generated from the dendritic cells and lymphocytes of an HIV-negative sibling may enable the body to recognize HIV more readily and increase immune response against the virus.

Detailed Description

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With lower CD4 counts, HIV-infected patients may not be able to produce dendritic cells and lymphocytes, special types of immune cells that generate HIV-specific CTLs. Infusion of CTLs generated from the dendritic cells and lymphocytes of an HIV-negative sibling may enable the body to recognize HIV more readily and increase immune response against the virus.

Dendritic cells and lymphocytes are obtained from an HIV-negative sibling. HIV-specific CTLs are generated from these cells and then infused into the HIV-infected patient monthly for 6 months. Siblings must be able to donate on multiple occasions, and patients are followed every 2-4 weeks during the study. Patients are screened over 3 months prior to study entry.

Conditions

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HIV Infections

Keywords

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Immunotherapy, Adoptive T-Lymphocyte Subsets T-Lymphocytes, Cytotoxic Dendritic Cells

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Lymphocytes, Activated

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients must have:

* HLA A2+.
* Other HLA matching with sibling.
* CD4 count 100-350 cells/mm3.
* No active opportunistic infection or malignancy (other than cutaneous Kaposi's sarcoma).
* Current stable antiviral regimen.
* Normal lab values and chest x-ray.

Donor siblings must have:

* HLA A2+.
* HIV negativity.
* Good venous access.
* Ability to donate on multiple occasions.
* Negative status for hepatitis B and C.

Exclusion Criteria

Concurrent Medication:

Excluded:

* Immunomodulators.
* Cytokines.
* Systemic steroids.
* IV pentamidine.
* Investigational drugs.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Stanford Univ School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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SPIRAT 2

Identifier Type: -

Identifier Source: org_study_id