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
Current as of December 10, 2023
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...
- Inclusion Criteria
- Concurrent Medication:
- 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.
- 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:
- Potentially immunosuppressive local therapy or radiation therapy for Kaposi's sarcoma within 4 weeks prior to study entry.
- Current substance abuse.
The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Boston, Massachusetts, United States
All reviews come from applied patients