Successful Discontinuation of the Placebo Arm and Provision of an Effective HIV Prevention Product After a Positive Interim Efficacy Result: The Partners PrEP Study Experience
Successful Discontinuation of the Placebo Arm and Provision of an Effective HIV Prevention Product After a Positive Interim Efficacy Result: The Partners PrEP Study Experience
复制标题
DOI：
10.1097/qai.0000000000000141
复制
发表时间：
2014-06-01
影响因子：
3.6
通讯作者：
Baeten, Jared M.
中科院分区：
文献类型：
--
作者：
Ndase, Patrick;Celum, Connie;Baeten, Jared M.
背景：向研究参与者和利益相关者传播研究结果，并在试验后立即提供经证明有效的产品，是开展生物医学艾滋病毒预防临床试验的核心要素。很少有生物医学艾滋病毒预防试验表明，艾滋病毒的保护与新的干预措施，因此，积极的试验结果和提供有效的产品的通信没有被测试在许多situations.Methods：在2011年7月，独立的数据和安全监测委员会的合作伙伴PrEP研究，一个随机的，安慰剂对照的疗效试验，每日口服抗逆转录病毒暴露前预防（PrEP）的艾滋病毒预防4747非洲异性恋艾滋病毒血清不一致的夫妇，建议中止试验的安慰剂组由于演示的PrEP疗效。我们描述了结果的传播，安慰剂组的中止，并提供积极的PrEP参与者'以前分配的placebo.Results：在72小时内，数据和安全监测委员会会议的研究结果被公开发布，并传播给利益相关者和研究参与者。在3个月内，研究方案进行了修改，允许最初分配到研究安慰剂组的参与者获得活性PrEP。在最初随机分配到安慰剂组的1418名参与者中，89.1%的参与者在临床上有资格接受PrEP。（1264/1418）表示同意。及时传播艾滋病毒预防试验的阳性结果，随后向研究参与者提供有效的产品，对于>东非4700对艾滋病毒血清不一致夫妇。研究申办者能够在多大程度上确保研究参与者持续获得产品仍然是未来艾滋病毒预防临床试验的讨论主题。
Background:Dissemination of research results to study participants and stakeholders and provision of proven effective products in the immediate post-trial period are core elements of the conduct of biomedical HIV prevention clinical trials. Few biomedical HIV prevention trials have demonstrated HIV protection with novel interventions, and thus, communication of positive trial results and provision of an effective product have not been tested in many situations.Methods:In July 2011, the independent Data and Safety Monitoring Board of the Partners PrEP Study, a randomized, placebo-controlled efficacy trial of daily oral antiretroviral preexposure prophylaxis (PrEP) for HIV prevention among 4747 African heterosexual HIV serodiscordant couples, recommended discontinuation of the trial's placebo arm due to demonstration of PrEP efficacy. We describe dissemination of results, discontinuation of the placebo arm, and provision of active PrEP to participants' formerly assigned placebo.Results:Within 72 hours, of the Data and Safety Monitoring Board meeting the study results were publicly released and disseminated to stakeholders and study participants. Within 3 months, the study protocol was modified to permit participants initially assigned to the study's placebo arm to be offered active PrEP. Of the 1418 participants initially randomized to placebo who were clinically eligible to receive PrEP, 89.1% (1264/1418) consented.Conclusions:Prompt dissemination of a positive HIV prevention trial result and subsequent provision of effective product to research participants was feasible and efficient for >4700 HIV serodiscordant couples in East Africa. The extent to which study sponsors can assure continued product access to research participants remains a subject of discussion for future HIV prevention clinical trials.