Safety of autologous, ex vivo-expanded human immunodeficiency virus (HIV)-specific cytotoxic T-lymphocyte infusion in HIV-infected patients.
J Lieberman, P R Skolnik, G R Parkerson...
https://pubmed.ncbi.nlm.nih.gov/9310470Completed
Phase 1
Age: 18Years +
All Genders
ID00000756
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
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-03
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 1 location
1
New England Med Ctr / Tufts Univ
Boston, Massachusetts, United States, 02111
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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