THE SETPOINT STUDY - A RANDOMIZED STUDY OF THE EFFECT OF IMMEDIATE TREATMENT
THE SETPOINT STUDY - A RANDOMIZED STUDY OF THE EFFECT OF IMMEDIATE TREATMENT
批准号:
7606118
负责人:
ERIC S DAAR
金额:
$0.31万
依托单位国家:
美国
项目类别:
财政年份:
2007
资助国家:
美国
项目状态:
已结题
起止时间:
2007-02-01 至 2007-11-30
关键词:
Adverse effectsAnti-HIV AgentsBloodCD4 Lymphocyte CountChronicComputer Retrieval of Information on Scientific Projects DatabaseDrug usageFundingGrantHIVHIV InfectionsImmune systemInstitutionLearningLopinavir/RitonavirMedicinePersonsPharmaceutical PreparationsRandomizedResearchResearch PersonnelResourcesSourceSymptomsTenofovirTimeUnited States Food and Drug AdministrationUnited States National Institutes of HealthViral Load resultVirusdesignemtricitabineimproved
中文摘要
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
在这项研究中,一组人将被告知立即开始服用抗HIV药物9个月。没有开始抗HIV药物的人,只有当他们的CD 4+计数降低或他们的病毒载量长时间保持高水平时,才会开始抗HIV药物。在研究结束时,将在研究开始时接受抗HIV药物的人的病毒载量与未开始抗HIV药物的人的病毒载量进行比较,以观察接受9个月治疗的人是否具有较低的病毒载量。众所周知,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。
英文摘要
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
During this study, one group of people will be told to immediately begin taking anti-HIV drugs for 9 months. People who do not begin anti-HIV drugs, will start anti-HIV drugs only when 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 persons who received the 9 months of treatment have a lower viral load. It is known that persons who keep lower viral loads tend to do better than persons with higher viral loads
The 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.
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