NCT00001064

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
Last Updated

December 14, 2016

Status Verified

April 1, 1995

First QC Date

November 2, 1999

Last Update Submit

December 13, 2016

Conditions

HIV Infections

Keywords

HIV AntigensImmunotherapy, AdoptiveDendritic Cells

Interventions

Allogenic Dendritic CellsDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Univ School of Medicine

Stanford, California, 943055107, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

December 14, 2016

Record last verified: 1995-04

Locations

US(1)