NCT00000824

Brief Summary

To define the safety of cytotoxic T lymphocytes (CTLs) generated from sibling-supplied dendritic cells and lymphocytes and infused into an HIV-infected patient. To determine the efficacy of these CTLs in helping the immune system to fight HIV. With lower CD4 counts, HIV-infected patients may not be able to produce dendritic cells and lymphocytes, special types of immune cells that generate HIV-specific CTLs. Infusion of CTLs generated from the dendritic cells and lymphocytes of an HIV-negative sibling may enable the body to recognize HIV 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

Click on a node to explore related trials.

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

Immunotherapy, AdoptiveT-Lymphocyte SubsetsT-Lymphocytes, CytotoxicDendritic Cells

Interventions

Lymphocytes, ActivatedDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients must have:
  • HLA A2+.
  • Other HLA matching with sibling.
  • CD4 count 100-350 cells/mm3.
  • No active opportunistic infection or malignancy (other than cutaneous Kaposi's sarcoma).
  • Current stable antiviral regimen.
  • Normal lab values and chest x-ray.
  • Donor siblings must have:
  • HLA A2+.
  • HIV negativity.
  • Good venous access.
  • Ability to donate on multiple occasions.
  • Negative status for hepatitis B and C.

You may not qualify if:

  • Concurrent Medication:
  • Excluded:
  • Immunomodulators.
  • Cytokines.
  • Systemic steroids.
  • IV pentamidine.
  • Investigational drugs.

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

Interventions

Lymphocyte Count

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Leukocyte CountBlood Cell CountCell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

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)