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

TRTMNT 含替诺福韦 DF、恩曲他滨、

• 批准号: 7719483
• 负责人: Elizabeth Connick
• 金额: $ 0.41万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7719483
• 关键词: Adverse effects; Anti-HIV Agents; Blood; CD4 Lymphocyte Count; Chronic; Computer Retrieval of Information on Scientific Projects Database; Drug usage; Early Diagnosis; Early treatment; Funding; Grant; Guidelines; HIV; HIV Infections; Immune System Part; Immune system; Infection; Institution; Learning; Lopinavir/Ritonavir; Medicine; Persons; Pharmaceutical Preparations; Research; Research Personnel; Resources; Running; Source; Symptoms; Tenofovir; Time; United States Food and Drug Administration; United States National Institutes of Health; Viral Load result; Virus; design; emtricitabine; fighting; improved

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 treatment.

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。 这项研究正在进行，以了解在早期艾滋病毒感染期间治疗是否有益。 换句话说，这项研究将评估抗HIV药物（Tenofovir DF，Emtricitabine和Kaletra）的组合对于最近获得的HIV感染者的安全性和有效性。 众所周知，联合抗艾滋病毒药物可以减少血液中的病毒量（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，当人们决定是否开始抗艾滋病毒药物时也要考虑这些副作用。 随着时间的推移，随着我们对抗艾滋病药物及其好的和坏的影响的了解越来越多，艾滋病治疗专家关于何时开始抗艾滋病药物的意见确实会发生变化。 本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HIV感染者。 有针对已确诊的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最近感染艾滋病毒的人，有证据表明，积极治疗感染早期诊断的人可能会有一些好处。 如果早期开始治疗，抵抗艾滋病毒感染的免疫系统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另一个人的可能性。 然而，我们仍然不知道从长远来看，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。 在本研究期间，将告知一组受试者立即开始服用抗HIV药物9个月。 未开始抗HIV药物治疗的受试者仅在其CD 4+计数降低或其病毒载量长时间保持高水平时才开始抗HIV药物治疗。 研究结束时，将研究开始时接受抗HIV药物治疗的受试者的病毒载量与未开始抗HIV药物治疗的受试者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。 我们确实知道，保持较低病毒载量的人往往比病毒载量较高的人做得更好。 这项研究的目的是，任何人谁需要治疗的艾滋病毒，因为高病毒载量，免疫系统下降或症状有关的艾滋病毒感染将提供治疗。