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
HIV Infections

About this trial
This is an interventional treatment trial for HIV Infections focused on measuring T-Lymphocytes, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Immunotherapy, Adoptive, Transplantation, Autologous
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.
Sites / Locations
- New England Med Ctr / Tufts Univ