A Pilot Study of HIV Specific Cytotoxic T Lymphocyte (CTL) Therapy in HIV-Infected Patients With CD4+ T Cells 100-350 Cells/mm3
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 试验地点
- 1
研究概览
简要总结
To define the safety of cytotoxic T lymphocytes (CTLs) generated from sibling-supplied dendritic cells and lymphocytes and infused into an HIV-infected patient. To determine the efficacy of these CTLs in helping the immune system to fight HIV.
With lower CD4 counts, HIV-infected patients may not be able to produce dendritic cells and lymphocytes, special types of immune cells that generate HIV-specific CTLs. Infusion of CTLs generated from the dendritic cells and lymphocytes of an HIV-negative sibling may enable the body to recognize HIV more readily and increase immune response against the virus.
详细描述
With lower CD4 counts, HIV-infected patients may not be able to produce dendritic cells and lymphocytes, special types of immune cells that generate HIV-specific CTLs. Infusion of CTLs generated from the dendritic cells and lymphocytes of an HIV-negative sibling may enable the body to recognize HIV more readily and increase immune response against the virus.
Dendritic cells and lymphocytes are obtained from an HIV-negative sibling. HIV-specific CTLs are generated from these cells and then infused into the HIV-infected patient monthly for 6 months. Siblings must be able to donate on multiple occasions, and patients are followed every 2-4 weeks during the study. Patients are screened over 3 months prior to study entry.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •Patients must have:
- •Other HLA matching with sibling.
- •CD4 count 100-350 cells/mm
- •No active opportunistic infection or malignancy (other than cutaneous Kaposi's sarcoma).
- •Current stable antiviral regimen.
- •Normal lab values and chest x-ray.
- •Donor siblings must have:
- •HIV negativity.
- •Good venous access.
- •Ability to donate on multiple occasions.
- •Negative status for hepatitis B and C.
排除标准
- •Concurrent Medication:
- •Immunomodulators.
- •Cytokines.
- •Systemic steroids.
- •IV pentamidine.
- •Investigational drugs.