A Pilot Study of Immunization With HIV-1 Antigen Pulsed Allogenic Dendritic Cells in HIV-Infected Asymptomatic Patients With CD4+ T Cells > 350 Cells/mm3

NCT ID: NCT00001064

Last Updated: 2016-12-14

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 and efficacy of sibling-supplied, HIV antigen-pulsed dendritic cells in increasing the immune response in HIV-infected patients.

Dendritic cells are a type of white blood cell used by the body to fight infection. They are instrumental in presenting antigens (such as HIV antigens) to the body's immune system. Since dendritic cells are not functioning maximally in HIV-infected patients, infusion of dendritic cells from an HIV-negative sibling may enable the affected sibling's immune system to recognize foreign particles more readily and increase immune response against the virus.

Detailed Description

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Dendritic cells are a type of white blood cell used by the body to fight infection. They are instrumental in presenting antigens (such as HIV antigens) to the body's immune system. Since dendritic cells are not functioning maximally in HIV-infected patients, infusion of dendritic cells from an HIV-negative sibling may enable the affected sibling's immune system to recognize foreign particles more readily and increase immune response against the virus.

Dendritic cells from an HIV-negative sibling are obtained and treated with various viral proteins (HIV vaccines) or immunomodulators. The treated dendritic cells are 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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HIV Antigens Immunotherapy, Adoptive Dendritic Cells

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Allogenic Dendritic Cells

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients must have:

* HLA A2+.
* Same cell type as donor sibling.
* CD4 count \> 350 cells/mm3.
* HIV asymptomatic status.
* No HIV antivirals during study.
* Normal labs and chest x-ray.

Donor siblings must have:

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

Exclusion Criteria

Concurrent Medication:

Excluded:

* Antiviral therapy (unless CD4 count declines to \< 350 cells/mm3).

Prior Medication:

Excluded:

* Antiviral therapy within 90 days prior to study entry.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

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 1

Identifier Type: -

Identifier Source: org_study_id