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)
Enter a location and click search to find clinical trials sorted by distance.
1
New England Med Ctr / Tufts Univ
Boston, Massachusetts, United States, 02111