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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 一项试验，以确定使用皮下（皮肤下）白介素（IL-2）是否会导致感染HIV但CD 4计数低于300/mm 3的患者的CD 4细胞计数升高。 在全世界，每100名15至49岁的成年人中约有一人感染艾滋病毒。估计有3 340万人感染艾滋病毒/艾滋病。尽管通过教育改变性行为的努力已经使一些地方的艾滋病毒感染率下降，但据预测，每天将有多达16 000人受到感染。 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不会导致病毒根除，并且不能保证维持病毒控制。因此，治疗必须不断改变。在明显病毒学控制的患者中，似乎存在“天花板效应”，至少在头两年，CD 4+细胞计数平均不能上升超过100至150个细胞/mm 3。CD 4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，可能是一种有用的方法，用于清除潜伏感染的CD 4+细胞中的HIV。 Proleukin是一种研究药物。本研究中的受试者已参与既往IL-2研究，并将进入本研究作为随访。几项研究表明，在皮肤下注射IL-2可以增加大多数受试者的CD 4+细胞计数。这项研究将观察IL-2与抗HIV药物的结合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。