PHASE III STUDY OF SUBCUTANEOUS RECOMBINANT IL-2 IN PATIENTS W/ HIV-1 INFECTION

HIV-1 感染患者皮下重组 IL-2 的 III 期研究

• 批准号: 7375123
• 负责人: DANIEL E NIXON
• 金额: $ 1.58万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7375123
• 关键词: PHASE; III; STUDY; SUBCUTANEOUS; RECOMBINANT

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.

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。一项试验旨在确定皮下(皮下)促白细胞介素2(IL-2)的使用是否会导致感染艾滋病毒但CD4计数低于300/mm3的患者的CD4细胞计数增加。在世界范围内，大约每100名15-49岁的成年人中就有一人感染艾滋病毒。据估计，这是3340万艾滋病毒/艾滋病患者。尽管改变性行为的教育努力已经导致一些地区艾滋病毒感染的下降，但预测每天将有多达1.6万人感染。在了解这种疾病和实施有效的治疗干预措施方面取得了很大进展。然而，这些有效的抗逆转录病毒药物组合并不能根除病毒，也不能保证维持病毒控制。因此，治疗方法必须不断改变。在病毒学明显控制的患者中，似乎存在“天花板效应”，至少在头两年，CD4+细胞计数未能平均上升超过100到150个细胞/mm3。CD4细胞是抵抗感染的免疫细胞。最近有人推测，Proil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的一种有效方法。普罗维林是一种研究用药物。这项研究的受试者参与了之前的IL-2研究，并将作为后续研究进入这项研究。一些研究表明，皮下注射IL-2可以增加大多数受试者的CD4+细胞数量。这项研究将观察IL-2与抗艾滋病毒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。它还将在几年内确定IL-2的安全性。