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

• Status: Completed
• Trial end date: 2002-06-01
• Target enrollment: 0
• Participant gender: All

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 the immunologic, virologic, and clinical changes for up to 24 weeks following infusion of study therapy.

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

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.