An open-label randomized clinical trial of novel therapeutic strategies for HIV-infected patients in whom antiretroviral therapy has failed: rationale and design of the OPTIMA Trial.

Kyriakides TC; Babiker A; Singer J; Cameron W; Schechter MT; Holodniy M; Brown ST; Youle M; Gazzard B

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An open-label randomized clinical trial of novel therapeutic strategies for HIV-infected patients in whom antiretroviral therapy has failed: rationale and design of the OPTIMA Trial.

机译：针对抗逆转录病毒疗法失败的HIV感染患者的新型治疗策略的开放标签随机临床试验：OPTIMA试验的原理和设计。

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OPTIMA (OPTions In Management with Antiretrovirals) is a clinical trial with a factorial randomization to evaluate the hypotheses that mega-antiretroviral therapy (ART) consisting of five or more anti-HIV drugs compared to standard-ART consisting of four or fewer anti-HIV drugs and a 3-month antiretroviral drug-free period (ARDFP) compared to no ARDFP will delay the occurrence of new or recurrent acquired immunodeficiency syndrome events or death, and prove to be more cost-effective in treating human immunodeficiency virus-infected individuals previously exposed to ART drugs from the current three main classes. The aim is to randomize 1,700 participants to four treatment strategy arms: (1) ARDFP+standard-ART; (2) ARDFP+mega-ART; (3) no ARDFP+standard-ART; (4) no ARDFP+mega-ART. The planned study duration is 3.5 years with 2.5 years of intake and a minimum 1 year of follow-up. The OPTIMA Trial was initiated in June 2001 at 30 U.S. Department of Veterans' Affairs hospitals, 22 hospitals in Canada, and 25hospitals in the United Kingdom. This is the first large-scale, multicenter, randomized controlled trial to compare the relative efficacy of these different therapeutic strategies. We discuss the rationale behind the OPTIMA Trial design as well as the issues arising from the conduct of a trial that involves three national clinical trial agencies.

机译：OPTIMA（使用抗逆转录病毒药物进行治疗的OPTions）是一项具有因子随机分配的临床试验，用于评估以下假设：大型抗逆转录病毒疗法（ART）包含五种或更多抗HIV药物，而标准ART包含四种或更少的抗HIV药物药物和没有ARDFP的3个月抗逆转录病毒无药期（ARDFP）将延迟新的或复发性获得性免疫缺陷综合症事件或死亡的发生，并证明在以前治疗人类免疫缺陷病毒感染的个体方面更具成本效益接触目前三个主要类别的抗逆转录病毒药物。目的是将1,700名参与者随机分配到四个治疗策略部门：（1）ARDFP + standard-ART; （2）ARDFP +巨型ART; （3）没有ARDFP + standard-ART; （4）没有ARDFP + mega-ART。计划的学习时间为3.5年，摄入2.5年，至少随访1年。 OPTIMA试用版于2001年6月在美国退伍军人事务部的30家医院，加拿大的22家医院和英国的25所医院开始。这是第一个比较这些不同治疗策略相对疗效的大规模，多中心，随机对照试验。我们讨论了OPTIMA试验设计背后的原理，以及涉及三个国家临床试验机构的试验所引起的问题。

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来源
《Controlled clinical trials》 |2003年第4期|共20页
作者
Kyriakides TC; Babiker A; Singer J; Cameron W; Schechter MT; Holodniy M; Brown ST; Youle M; Gazzard B;
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正文语种 eng
中图分类临床医学;
关键词
Anti-HIV Agents; HIV Infections; 抗HIV药; HIV感染;

机译：Anti-HIV Agents;HIV Infections;抗HIV药;HIV感染;

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1. An open-label randomized clinical trial of novel therapeutic strategies for HIV-infected patients in whom antiretroviral therapy has failed: rationale and design of the OPTIMA Trial. [J] . Kyriakides TC, Babiker A, Singer J, Controlled clinical trials . 2003,第4期

机译：针对抗逆转录病毒疗法失败的HIV感染患者的新型治疗策略的开放标签随机临床试验：OPTIMA试验的原理和设计。
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An open-label randomized clinical trial of novel therapeutic strategies for HIV-infected patients in whom antiretroviral therapy has failed: rationale and design of the OPTIMA Trial.

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