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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00001064
• Other study ID #: SPIRAT 1
• Status: Terminated
• Phase: N/A
• First received: November 2, 1999
• Last updated: December 13, 2016
• Est. completion date: June 2005

Study information

• Verified date: April 1995
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Allogenic Dendritic Cells

Locations

Country	Name	City	State
United States	Stanford Univ School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States,