TRTMNT W/TENOFOVIR DF,EMTRICITABINE,& LOPINAVIR/RITONAVIR VS NO THERAPY IN HIV

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。这项研究是为了了解在HIV感染早期对患者进行治疗是否有益。换句话说，这项研究将评估抗艾滋病毒药物（替诺福韦DF，恩曲他滨和卡雷特拉）的组合对最近获得艾滋病毒感染的人的安全性和有效性。众所周知，联合抗hiv药物可以减少血液中的病毒数量（病毒载量）并改善免疫系统。然而，这些药物也有短期和长期的副作用，这也是人们决定是否开始抗艾滋病毒药物时考虑的因素。随着我们对抗艾滋病毒药物的了解越来越多，以及它们的好坏影响，艾滋病毒治疗专家关于何时开始抗艾滋病毒药物的观点确实发生了变化。这项研究中使用的三种药物已被美国食品和药物管理局批准用于治疗慢性艾滋病毒感染者。有针对慢性艾滋病毒感染者的治疗指南。我们不知道最近感染艾滋病毒的人的情况是否会有所不同。几年来，研究人员一直在研究新近感染艾滋病毒的人，有一些证据表明，积极治疗在感染早期被诊断出来的人可能会有一些好处。如果及早开始治疗，免疫系统中对抗HIV感染的部分可能会得到更好的保护。艾滋病毒感染的早期治疗可能会降低感染传播给他人的可能性。然而，从长远来看，我们仍然不知道治疗早期艾滋病毒感染是否会产生影响。我们不知道早期开始治疗的副作用是否合理。在这项研究中，一组受试者将被告知立即开始服用抗艾滋病毒药物9个月。没有开始服用抗hiv药物的受试者，只有当他们的CD4+计数下降或病毒载量长时间保持高水平时，才会开始服用抗hiv药物。在研究结束时，将研究开始时接受抗hiv药物治疗的人的病毒载量与未开始抗hiv药物治疗的人的病毒载量进行比较，以观察接受9个月治疗的受试者的病毒载量是否较低。我们知道，病毒载量低的人往往比病毒载量高的人做得更好。这项研究的目的是让任何因病毒载量高、免疫系统下降或与艾滋病毒感染有关的症状而需要治疗的人都能得到治疗

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. This study is being done to learn if treating people during early HIV infection is beneficial. In other words, this study will evaluate how safe and effective a combination of anti-HIV drugs (Tenofovir DF, Emtricitabine and Kaletra) is for people with recently acquired HIV infection. It is known that combination anti-HIV drugs decreases the amount of virus in the blood (viral load) and improve the immune system. However, these drugs also have short-term and long-term side effects that are also considered when people decide whether or not to begin anti-HIV medicine. The opinions of HIV treatment experts regarding when to start anti-HIV medicine do change as we learn more about the anti-HIV drugs and their good and bad effects over time. The three drugs used in this study have been approved of by the U.S. Food and Drug Administration for the treatment of people with chronic HIV infection. There are treatment guidelines for persons with chronic, established HIV infection. We do not know if the situation may be different for persons recently infected with HIV. For several years, investigators have been studying people with recently acquired HIV infection, and there is some evidence that aggressively treating people diagnosed early during their infection may be of some benefit. The part of the immune system that fights HIV infection may be better preserved if treatment is begun early. Early treatment of HIV infection may possibly make it less likely that the infection is spread to another person. However, we still do not know whether or not treating early HIV infection makes a difference in the long run. We do not know if the side effects associated with beginning treatment earlier are justified. During this study, one group of subjects will be told to immediately begin taking anti-HIV drugs for 9 months. The subjects who do not begin anti-HIV drugs, will start anti-HIV drugs only if their CD4+ count goes low or their viral load stays high for a long period of time. At the end of the study, the viral load in persons who received anti-HIV drugs at the beginning of the study will be compared to the viral load in persons who did not start anti-HIV drugs, to see if the subjects who received the 9 months of treatment have a lower viral load. We do know that people who keep lower viral loads tend to do better than people with higher viral loads. This study is designed so that anyone who needs treatment for HIV because of high viral load, immune system decline or symptoms related to HIV infection will be offered treatm