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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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-specific proteins. Administration of these cytotoxic T lymphocytes (CTLs) may help prevent HIV disease progression.

AMENDED 03/28/94:

Patients are not accrued at the 25 billion CTL dose. Instead, a third cohort receives three infusions of 1 billion CTL 5-8 weeks apart.

AMENDED 02/14/94:

Patients infused with 1 or 5 billion CTL will be reinfused with 1 billion CTL 6-12 months later, and then f...

Gender

ALL

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.