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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。一项试验，以确定是否使用皮下（皮肤下）白细胞介素（IL-2）导致CD4细胞计数较高的患者感染艾滋病毒，但CD4细胞计数低于300/mm3。在世界范围内，大约每100名15至49岁的成年人中就有一人感染艾滋病毒。估计有3340万人感染艾滋病毒/艾滋病。尽管改变性行为的教育努力使一些地区的艾滋病毒感染率有所下降，但据预测，每天将有多达16 000人受到感染。在了解该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能根除病毒，也不能保证维持病毒控制。因此，治疗必须不断改变。在病毒学得到明显控制的患者中，至少在头两年，CD4+细胞计数平均上升超过100至150个细胞/mm3，似乎存在“天花板效应”。CD4细胞是对抗感染的免疫细胞。最近有人推测，白细胞原素联合强效抗病毒治疗可能是清除潜伏感染的CD4+细胞中的HIV的有效方法。白细胞原素是一种研究药物。本研究的受试者已经参加了之前的IL-2研究，并将作为随访进入本研究。几项研究表明，皮下注射IL-2可以增加大多数受试者的CD4+细胞计数。这项研究将观察IL-2与抗hiv药物联合使用是否能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。

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.