Status:

COMPLETED

Evaluation of the Safety and Tolerance of Immunotherapy With Autologous, Ex-Vivo Expanded, HIV-Specific Cytotoxic T-Cells in HIV-Infected Patients With CD4+ Counts Between 100-400/mm3

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

HIV Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

To determine the safety, tolerance, and feasibility of adoptive immunotherapy with autologous cytotoxic T-lymphocytes (CTLs) in HIV-infected patients with CD4 counts between 100 and 400; to evaluate t...

Detailed Description

Freshly isolated peripheral blood lymphocytes from HIV-1-seropositive individuals frequently lyse autologous HIV-1-expressing cells or autologous cells infected with vaccinia vectors encoding HIV-1-sp...

Eligibility Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Approved antiretroviral therapy and/or prophylactic PCP therapy, provided there was no change in such therapy in the 4 weeks prior to study entry.
  • Other approved treatments for HIV-related diseases that are not known to affect cellular immune response.
  • G-CSF.
  • Erythropoietin.
  • Supportive care for acute therapy-related toxicity.

Patients must have:

  • HIV infection.
  • CD4 count 100 - 400 cells/mm3.
  • No current or previously documented AIDS-related opportunistic infection, malignancy, or encephalopathy other than mild Kaposi's sarcoma.
  • FEV1 > 70 percent, DLCO > 50 percent predicted for height and age (initial infusion only).
  • T cell lines with specific cytotoxicity against HIV-1.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Significant autoimmune disease.
  • Non-AIDS-associated malignancy.
  • Symptoms of cardiac disease.
  • Dyspnea on significant exertion.
  • Acute infiltrates on chest radiographs.

Patients with the following prior conditions are excluded:

  • History of significant arrhythmia, infarction, or heart failure.
  • History of a major psychiatric illness.

Prior Medication:

Excluded within 4 weeks prior to study entry:

  • Systemic immunosuppressive therapy (i.e., steroids, cyclosporine, chemotherapy, or alpha-interferon).
  • Therapy for acute infection, AIDS-related opportunistic infection, or malignancy.
  • Experimental AIDS therapy.

Prior Treatment:

Excluded:

  • Potentially immunosuppressive local therapy or radiation therapy for Kaposi's sarcoma within 4 weeks prior to study entry.

Current substance abuse.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

June 1 2002

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT00000756

End Date

June 1 2002

Last Update

November 3 2021

Active Locations (1)

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Page 1 of 1 (1 locations)

1

New England Med Ctr / Tufts Univ

Boston, Massachusetts, United States, 02111