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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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 followed for up to 12 weeks after the reinfusion.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Erythropoietin.
- •Supportive care for acute therapy-related toxicity.
- •Patients must have:
- •HIV infection.
- •CD4 count 100 - 400 cells/mm
- •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.
排除标准
- •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.