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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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001064
First Posted: August 31, 2001
Last Update Posted: December 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose

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.


Condition Intervention
HIV Infections Drug: Allogenic Dendritic Cells

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001064


Locations
United States, California
Stanford Univ School of Medicine
Stanford, California, United States, 943055107
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

ClinicalTrials.gov Identifier: NCT00001064     History of Changes
Other Study ID Numbers: SPIRAT 1
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 14, 2016
Last Verified: April 1995

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Antigens
Immunotherapy, Adoptive
Dendritic Cells

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs