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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

Primary Purpose

HIV Infections

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Allogenic Dendritic Cells
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV Antigens, Immunotherapy, Adoptive, Dendritic Cells

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford Univ School of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
December 13, 2016
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00001064
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 1995
Overall Recruitment Status
Terminated
Study Start Date
undefined (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV Antigens, Immunotherapy, Adoptive, Dendritic Cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Allogenic Dendritic Cells

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Stanford Univ School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
943055107
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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