A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of a Chemokine Receptor 5 (CCR5) Antagonist to Decrease the Occurrence of Immune Reconstitution Inflammatory Syndrome in HIV-Infection: The CADIRIS Study.-猫眼课题宝

DOI：

10.1016/s2352-3018(14)70027-x

发表时间：

2014-11-01

期刊：

The lancet. HIV

影响因子：

通讯作者：

中科院分区：

其他

文献类型：

作者：

Sierra-Madero JG;Ellenberg S;Rassool MS;Tierney A;Belaunzarán-Zamudio PF;López-Martínez A;Piñeirúa-Menéndez A;Montaner LJ;Azzoni L;Benítez CR;Sereti I;Andrade-Villanueva J;Mosqueda-Gómez JL;Rodriguez B;Sanne I;Lederman MM;CADIRIS study team

来源链接：

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4563882/?report=classic

免疫重建炎症综合征(IRIS)是HIV感染者抗逆转录病毒治疗(ART)的常见并发症。虹膜与住院和死亡风险增加有关。我们确定了使用马拉韦罗阻断CCR5是否降低了IRIS的风险。CADIRIS研究是一项随机、双盲、安慰剂对照的临床试验，于2009年11月至2012年1月期间从墨西哥的五个临床地点和南非的一个临床地点收集受试者，并对他们进行了一年的跟踪调查。主要结果是24周后出现IRIS。HIV感染者，天真的ART，CD_4细胞100/μ，L，HIVRNA&gt；1000拷贝/毫升符合条件。我们筛选了362名受试者；279名符合纳入标准，3名拒绝参与，276名随机。参与者每天两次服用马拉韦罗600毫克，或在ART方案中加入安慰剂，其中包括替诺福韦、恩曲他滨和依法韦仑，为期48周。有276名患者被随机分组(140名接受马拉韦罗治疗，136名接受安慰剂治疗)。两组患者发生IRIS事件的时间差异无统计学意义(HR1.08，95%CI(0.66，1.77)，对数列检验p=0.743)。总体而言，(23%)患者发生IRIS事件，马拉韦罗组33例(24%)，安慰剂组31例(23%)(p=0.88)。在ART开始后，马拉韦罗对IRIS事件的频率、时间或严重程度没有显著影响。在最初的治疗方案中包括CCR5抑制剂并不能有效地防止晚期艾滋病毒感染者发生IRIS。这项试验是由美国纽约辉瑞公司的调查员发起的研究资助的。临床试验.gov。ID：NCT00988780(http://clinicaltrials.gov/ct2/show/NCT00988780)

Immune Reconstitution Inflammatory Syndrome (IRIS) is a common complication of antiretroviral therapy (ART) in HIV-infected patients. IRIS is associated with an increased risk of hospitalization and death. We ascertained whether CCR5 blockade using maraviroc reduces the risk of IRIS. The CADIRIS study was a randomized, double-blind, placebo-controlled, clinical trial that accrued subjects from five clinical sites in Mexico and one in South Africa between November 2009 and January 2012, and followed them for one year. The primary outcome was occurrence of IRIS by 24 weeks. HIV-infected adults, naïve to ART, with CD4 cells <100/μL, and HIVRNA >1,000 copies/mL were eligible. We screened 362 subjects; 279 met inclusion criteria, 3 refused participation, and 276 were randomized. Participants received maraviroc 600 mg twice daily or placebo added to an ART regimen that included tenofovir, emtricitabine, and efavirenz for 48 weeks. There were 276 patients randomized (140 received maraviroc and 136 placebo). There was no difference in the time to IRIS events between treatment arms (HR 1·08, 95% CI (0·66, 1·77), log-rank test p=0·743). In total, 64 (23%) patients had IRIS events, 33 (24%) in the maraviroc arm and 31 (23%) in the placebo arm (p=0·88). Maraviroc had no significant effect on frequency, time or severity of IRIS events after ART initiation. Including a CCR5 inhibitor in an initial treatment regimen does not confer a meaningful protection from the occurrence of IRIS in persons with advanced HIV infection. The trial was funded as investigator initiated research by Pfizer Inc, New York, NY, USA. ClinicalTrials.gov. ID: NCT00988780 (http://clinicaltrials.gov/ct2/show/NCT00988780)

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of a Chemokine Receptor 5 (CCR5) Antagonist to Decrease the Occurrence of Immune Reconstitution Inflammatory Syndrome in HIV-Infection: The CADIRIS Study.

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