TRIAL COMPARING TWO STRATEGIES FOR MANAGEMENT OF ANTIRETROVIRAL THERAPY

比较两种抗逆转录病毒治疗管理策略的试验

• 批准号: 7376352
• 负责人: DAVID M MUSCHATT
• 金额: $ 10.8万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376352
• 关键词: TRIAL; COMPARING; TWO; STRATEGIES; MANAGEMENT

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.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。SMART研究正在进行，因为尽管抗HIV/AIDS药物可用，但医疗保健提供者仍然对使用这些药物治疗HIV感染者的最佳方法存在疑问。许多医疗保健提供者现在用日常药物治疗患者，以保持血液中病毒的数量（病毒载量）尽可能低。我们知道，这种使用抗艾滋病毒药物的方法非常有效，可以帮助CD 4计数低于200-250个细胞的人在没有严重疾病的情况下活得更长。但我们不知道这是否是多年来使用抗HIV药物治疗CD 4计数较高的HIV患者的最佳方法。 有信息表明，患者可能可以等待使用抗艾滋病毒药物，因为患病的风险似乎很低，而CD 4细胞计数高于250个细胞。我们不确定等待使用抗艾滋病毒药物是否比在较高的CD 4计数下使用抗艾滋病毒药物更好。用于指导医疗保健提供者和患者治疗艾滋病毒疾病的大多数信息来自在短时间内进行的不同类型的研究。 需要一种新的研究，这种研究需要几年的时间。为了帮助医疗服务提供者和患者决定如何使用抗艾滋病毒治疗多年，SMART研究将比较两种在大量艾滋病毒感染者中使用抗艾滋病毒药物的方法，并长期随访。 抗逆转录病毒治疗准则强调对大多数艾滋病毒感染者最大限度和持久地抑制病毒载量，这些准则的实施已导致发病率和死亡率大幅下降。然而，许多无症状患者不会立即面临严重机会性疾病的风险，抗逆转录病毒疗法的有效性会因艾滋病毒耐药性而随着时间的推移而减弱，而且治疗存在短期和长期毒性。这激发了两种策略的比较，一种是通过推迟使用而节省治疗，同时机会性疾病的风险较低，另一种是旨在持续抑制病毒，而不考虑疾病风险。