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: 7604433
• 负责人: Elizabeth Connick
• 金额: $ 2.1万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-07-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604433
• 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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 这项研究的目的是了解治疗早期艾滋病毒感染者是否有益。 换句话说，这项研究将评估抗 HIV 药物（替诺福韦 DF、恩曲他滨和克力芝）组合对于最近感染 HIV 的人的安全性和有效性。 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。 随着我们对抗艾滋病毒药物及其随着时间的推移的好坏影响了解得更多，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。 本研究中使用的三种药物已获得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。 对于慢性、已确诊的艾滋病毒感染者有治疗指南。 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。 多年来，研究人员一直在研究最近感染艾滋病毒的人，有一些证据表明，积极治疗感染早期诊断出的人可能会有所帮助。 如果及早开始治疗，免疫系统中抵抗艾滋病毒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另一个人的可能性。 然而，我们仍然不知道治疗早期艾滋病毒感染从长远来看是否会产生影响。 我们不知道与早期开始治疗相关的副作用是否合理。 在这项研究中，一组受试者将被告知立即开始服用抗 HIV 药物，为期 9 个月。 不开始使用抗HIV药物的受试者，只有当他们的CD4+计数变低或者病毒载量长时间保持在高水平时才会开始使用抗HIV药物。 在研究结束时，将在研究开始时接受抗HIV药物的受试者的病毒载量与未开始抗HIV药物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，病毒载量较低的人往往比病毒载量较高的人做得更好。 这项研究的目的是为任何因高病毒载量、免疫系统下降或与艾滋病毒感染相关的症状而需要艾滋病毒治疗的人提供治疗。