TRIAL COMPARING TWO STRATEGIES FOR MANAGEMENT OF ANTIRETROVIRAL THERAPY

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。之所以进行这项明智的研究，是因为尽管有抗艾滋病毒/艾滋病的药物可用，但医疗保健提供者仍然对使用这些药物治疗艾滋病毒携带者的最佳方式存在疑问。许多医疗保健提供者现在用日常药物治疗患者，以便将血液中的病毒数量(病毒载量)保持在尽可能低的水平。我们知道，这种使用抗艾滋病毒药物的方法非常有效地帮助CD4计数低于200-250个细胞的人活得更长，而不会发生严重疾病。但我们不知道这是否是多年来使用抗HIV药物治疗CD4计数较高患者的HIV疾病的最佳方式。有信息表明，患者可能可以等待使用抗艾滋病毒药物，因为当CD4计数高于250个细胞时，患病的风险似乎很低。我们不确定等待使用抗艾滋病毒药物是否比在CD4计数较高的情况下使用抗艾滋病毒药物更好。大多数用于指导医疗保健提供者和患者关于艾滋病毒疾病治疗的信息来自于在短时间内进行的不同类型的研究。需要进行一种历时数年的新研究。为了帮助医疗保健提供者和患者决定如何在多年内使用抗艾滋病毒治疗，这项聪明的研究将比较在大量艾滋病毒感染者中使用抗艾滋病毒药物的两种方式，并对它们进行长期跟踪。实施抗逆转录病毒治疗指南，强调最大限度和持久地抑制大多数艾滋病毒感染者的病毒载量，已导致发病率和死亡率大幅下降。然而，许多无症状的患者并不立即面临严重机会性疾病的风险，由于艾滋病毒耐药性，抗逆转录病毒治疗的有效性随着时间的推移而减弱，治疗既有短期毒性，也有长期毒性。这促使对两种策略进行比较，一种是在机会性疾病风险较低的情况下通过推迟使用来节省治疗，另一种是无论疾病风险如何，旨在持续的病毒学抑制。

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. The SMART study is being done because, although anti-HIV/AIDS drugs are available, healthcare providers still have questions about the best ways to use these drugs to treat people living with HIV. Many healthcare providers now treat patients with daily drugs in order to keep the amount of virus in the blood (viral load) as low as possible. We know that this approach to using anti-HIV drugs is very effective in helping people with CD4 counts less than 200-250 cells live longer without serious diseases. But we do not know if this is the best way to use anti-HIV drugs to treat HIV disease in patients with higher CD4 counts over many years. There is information suggesting that patients may be able to wait to use anti-HIV drugs because the risk of getting sick appears low while CD4 counts are higher than 250 cells. We are not sure if waiting to use anti-HIV drugs is better than using anti-HIV drugs at higher CD4 counts. Most information used to guide healthcare providers and patients about the treatment of HIV disease comes from different types of studies that were carried out over a short period of time. A new kind of study that is carried out over several years is needed. To help healthcare providers and patients decide how to use anti-HIV treatments over many years, the SMART study will compare two ways of using anti-HIV drugs in a large number of HIV-infected people and follow them over a long period of time. Implementation of antiretroviral treatment guidelines, which emphasize maximal and durable suppression of viral load for the majority of individuals infected with HIV, has resulted in a substantial decline in morbidity and mortality. However, many asymptomatic patients are not at immediate risk of serious opportunistic diseases, the effectiveness of antiretroviral therapy wanes over time due to HIV drug resistance, and there are both short- and long-term toxicities of treatment. This motivates a comparison of two strategies, one which conserves treatments by deferring their use while the risk of opportunistic disease is low and one which aims for sustained virologic suppression irrespective of disease risk.