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HIV-2 infection: a call for controlled trials

机译:HIV-2感染:需要进行对照试验

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The paper by Gottlieb et al. recalls the particularities of HIV-2 infection and calls for dedicated randomized controlled trials of antiretroviral therapy in West Africa. Randomized trials are indeed the only way of determining most effective antiretroviral combination(s) for both antiretroviral-naive and antiretroviral-experienced patients.Many HIV-2-infected patients live in parts of western Europe with historical ties to West Africa, especially France and Portugal. However, their numbers are insufficient for conclusive randomized trials. The ACHIeV_2E network of clinicians, virologists, immunol-ogists, epidemiologists and statisticians belonging to research centers located in 10 countries in Europe and two in West Africa was created to conduct such trials and thus to establish international guidelines for the treatment and management of HIV-2-infected patients. The design, inclusion criteria, endpoints for efficacy and statistical methods of trials designed to define the optimal treatment for HIV-2 infection should theoretically be the same as those used for HIV-1, in terms of methodological rigor and statistical power. But certain particularities of HIV-2 infection must be taken into account when designing such studies, and the first step is to identify the prerequisites and constraints resulting from this requirement. The main issues concern the target population, the best candidate drugs and combinations, and the therapeutic strategies that warrant testing. Another question is whether the endpoints and statistical methods used to analyze the response to treatment for HIV-1 infection are also appropriate for HIV-2 infection.
机译:Gottlieb等人的论文。回顾了HIV-2感染的特殊性,并呼吁在西非进行专门的抗逆转录病毒疗法随机对照试验。确实,随机试验是确定对初次使用抗逆转录病毒药物和经验丰富的患者最有效的抗逆转录病毒药物组合的唯一方法。许多感染HIV-2的患者生活在西欧与西非有历史渊源的地区,尤其是法国和葡萄牙。但是,它们的数量不足以进行最终的随机试验。建立了ACHIeV_2E网络,由位于欧洲10个国家和西非两个国家的研究中心的临床医生,病毒学家,免疫学家,流行病学家和统计学家组成,以进行此类试验,从而建立有关HIV- 2感染的患者。从方法学上的严谨性和统计能力的角度来看,旨在定义针对HIV-2感染的最佳治疗方法的设计,纳入标准,疗效终点和试验的统计方法,从理论上讲应与HIV-1所用的相同。但是在设计此类研究时,必须考虑到HIV-2感染的某些特殊性,第一步是确定由该要求引起的先决条件和制约因素。主要问题涉及目标人群,最佳候选药物和组合以及需要进行测试的治疗策略。另一个问题是,用于分析对HIV-1感染的治疗反应的终点和统计方法是否也适用于HIV-2感染。

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