CLINICAL TRIAL: PHASE III STUDY OF SUBCUTANEOUS RECOMBINANT IL-2 IN PATIENTS W/

临床试验：皮下重组 IL-2 在患者中的 III 期研究

• 批准号: 7717012
• 负责人: DANIEL W NIXON
• 金额: $ 2.71万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717012
• 关键词: AIDS/HIV problem; Adult; Aldesleukin; Anti-HIV Agents; Anti-Retroviral Agents; Antiviral Therapy; CD4 Lymphocyte Count; CD4 Positive T Lymphocytes; Cells; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Disease; Drug Combinations; Failure; Funding; Grant; HIV; HIV Infections; Immune; Infection; Injection of therapeutic agent; Institution; Interleukin-2; Investigational Drugs; Life; Location; Maintenance; Patients; Phase; Recombinants; Research; Research Personnel; Resources; Safety; Sex Behavior; Skin; Source; Therapeutic Intervention; United States National Institutes of Health; Viral; aged; day; fight against; follow-up; purge; subcutaneous

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. A trial to determine if the use of subcutaneous (under the skin) proleukin (IL-2) results in higher CD4 cell counts in patients infected with HIV, but having a CD4 count less than 300/mm3. Worldwide, approximately one in every 100 adults aged 15-49 is HIV infected. This is an estimated 33.4 million people living with HIV/AIDS. Even though educational efforts to modify sexual behaviors have resulted in a decline of HIV infection in some locations, the prediction is that as many as 16,000 people will become infected each day. Much progress has been made in understanding the disease and in implementing potent therapeutic interventions. However, these potent antiretroviral drug combinations do not result in viral eradication and cannot guarantee maintenance of viral control. Thus, treatment must be continuously changed. Among patients with apparent virologic control, a "ceiling effect" seems to exist with failure of CD4+ cell counts to rise on an average of more than 100 to 150 cells/mm3, at least during the first two years. CD4 cells are immune cells that fight against infection. It has recently been speculated that proleukin, in combination with potent antiviral therapy may be a useful approach for purging HIV from the latently infected CD4+ cells. Proleukin is an investigational drug. Subjects in this study have participated in a previous IL-2 study and will enter this study as a follow-up. Several studies have shown that an injection of IL-2 under the skin can increase CD4+ cell counts in most subjects. This study will see if IL-2, in combination with anti-HIV drugs, can cut down on serious infections and prolong the lives of these patients. It will also determine the safety of IL-2 over several years.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 一项试验，旨在确定皮下（皮下）白细胞介素 (IL-2) 的使用是否会导致感染 HIV 的患者 CD4 细胞计数升高，但 CD4 细胞计数低于 300/mm3。 在世界范围内，大约每 100 名 15-49 岁成年人中就有 1 人感染艾滋病毒。据估计，有 3,340 万名艾滋病毒/艾滋病感染者。尽管改变性行为的教育努力已导致某些地区艾滋病毒感染率下降，但预计每天将有多达 16,000 人被感染。 在了解这种疾病和实施有效的治疗干预方面已经取得了很大进展。然而，这些有效的抗逆转录病毒药物组合不会导致病毒根除，也不能保证维持病毒控制。因此，治疗必须不断改变。在病毒学明显控制的患者中，似乎存在“天花板效应”，即 CD4+ 细胞计数未能以平均 100 至 150 个细胞/mm3 的速度上升，至少在前两年是这样。 CD4 细胞是抵抗感染的免疫细胞。最近有人推测，proleukin 与有效的抗病毒治疗相结合可能是从潜伏感染的 CD4+ 细胞中清除 HIV 的有效方法。 Proleukin 是一种研究药物。本研究的受试者已参加过之前的 IL-2 研究，并将作为后续研究进入本研究。多项研究表明，皮下注射 IL-2 可以增加大多数受试者的 CD4+ 细胞计数。这项研究将了解 IL-2 与抗 HIV 药物联合使用是否可以减少严重感染并延长这些患者的生命。它还将确定 IL-2 在数年内的安全性。