A5142:COMPARISON OF TREATMENT FOR INITIAL THERAPY OF HIV INFECTION

A5142：HIV 感染初始治疗的比较

• 批准号: 7377996
• 负责人: ROBERT C KALAYJIAN
• 金额: $ 0.26万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7377996
• 关键词: A5142; COMPARISON; TREATMENT; INITIAL; THERAPY

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. ACTG A5142- This is a Phase III, randomized, three arm, open-label study comparing three different anti-HIV drug regimens as first-time treatments for HIV infection. The study will look at the effectiveness and safety of the three drug regimens and how well these regimens are tolerated. People treated for HIV sometimes develop high blood sugar, higher than normal levels of fats (such as triglycerides and cholesterol) in their blood, loss of fat from the arms and legs, or increased fat in other parts of the body such as the upper back and abdomen. Therefore, the study will also look at the effect of these three HIV regimens on changes in metabolism. The anti-HIV drugs to be used in this study are lopinavir/ritonavir (LPV/RTV), efavirenz (EFV), zidovudine (ZDV), lamivudine (3TC), Combivir (the combination of ZDV and 3TC in a single tablet), stavudine extended release (d4T XR), and tenofovir (TDF). All of these drugs have been approved by the U. S. Food and Drug Administration (FDA) for the treatment of HIV infection. Studies have shown that these drugs are effective against HIV infection when used with each other. However, there is not much information available on the combination of EFV and LPV/RTV, which is one of the regimens being studied in this protocol. Subjects will be stratified at randomization by screening plasma HIV-1 RNA, chronic hepatitis infection and selection of NRTI. Subjects will receive treatment for 96 weeks after the last subject is enrolled. Subjects will have anthropometic measurements, several blood test, urinalysis, pregnancy test and Dexa scans.

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。ACTG A5142——这是一项III期、随机、三组、开放标签的研究，比较了三种不同的抗HIV药物方案作为HIV感染的首次治疗。该研究将考察这三种药物方案的有效性和安全性，以及这些方案的耐受性。接受艾滋病毒治疗的人有时会出现高血糖，血液中的脂肪（如甘油三酯和胆固醇）高于正常水平，手臂和腿部的脂肪减少，或身体其他部位（如上背部和腹部）的脂肪增加。因此，该研究还将研究这三种HIV治疗方案对新陈代谢变化的影响。本研究拟使用的抗hiv药物有洛匹那韦/利托那韦（LPV/RTV）、依非韦伦（EFV）、齐多夫定（ZDV）、拉米夫定（3TC）、康比韦（ZDV与3TC合用）、司他夫定缓释（d4T XR）、替诺福韦（TDF）。所有这些药物都已被美国食品和药物管理局（FDA）批准用于治疗HIV感染。研究表明，当这些药物相互使用时，它们对艾滋病毒感染是有效的。然而，关于EFV和LPV/RTV联合使用的信息并不多，这是本方案正在研究的方案之一。受试者将通过筛查血浆HIV-1 RNA、慢性肝炎感染和选择NRTI进行随机分层。受试者将在最后一名受试者入组后接受为期96周的治疗。受试者将进行人体测量、几项血液测试、尿液分析、妊娠测试和Dexa扫描。