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首页> 外文期刊>BioResearch open access. >A Pilot Study of Raltegravir Plus Combination Antiretroviral Therapy in Early Human Immunodeficiency Virus Infection: Challenges and Lessons Learned
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A Pilot Study of Raltegravir Plus Combination Antiretroviral Therapy in Early Human Immunodeficiency Virus Infection: Challenges and Lessons Learned

机译：Raltegravir联合抗逆转录病毒疗法在早期人类免疫缺陷病毒感染中的初步研究：挑战和经验教训

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Availability of integrase strand transfer inhibitors created interest in determining whether their use would decrease persistently infected cell numbers. This study hypothesized that adding raltegravir (RAL) to standard antiretroviral therapy (ART) would decrease human immunodeficiency virus (HIV)-infected CD4+ T cells more than standard combination ART. This was a pilot, randomized study comparing open-label standard triple ART to standard triple ART plus RAL over 96 weeks in ART-naive adults with early HIV infection. The primary objective was to compare quantity and trajectory of HIV DNA. Eighty-two persons were referred. A diverse set of reasons precluded the enrollment of all but 10. Those who enrolled and completed the study had an estimated median duration of HIV infection of 74 days at ART start. The groups had similar baseline characteristics. The RAL group had more rapid first phase plasma HIV RNA decay (0.67?log10 copies/mL/day) than with combination ART (0.34?log10copies/mL/day), p =?0.037. Second phase HIV RNA decay, residual viremia, cell-associated RNA, HIV DNA, CD4+ T-cells with replication-competent virus, and 2LTR circle levels did not differ between groups. Among those with entry plasma HIV RNA levels above the median, 2LTR circles were significantly lower over time than in those with lower entry HIV RNA levels ( p =?0.02). Our results suggest homogeneity of responses in cell-associated RNA, HIV DNA, CD4+ T-cells with replication-competent virus, and 2LTR circles with early HIV in both ART groups. The kinetics of 2LTR DNA did not reflect the kinetics of plasma HIV RNA decline following ART initiation.
机译：整合酶链转移抑制剂的可用性引起了人们的兴趣，以确定它们的使用是否会减少持续感染的细胞数量。这项研究假设，在标准抗逆转录病毒疗法（ART）中添加raltegravir（RAL）会比标准组合ART减少更多的人类免疫缺陷病毒（HIV）感染的CD4 + T细胞。这是一项试验性随机研究，比较了在96天内接受过首次HIV感染的未接受过治疗的成年人中，开放标签的标准三联抗逆转录病毒疗法与标准三联抗逆转录病毒疗法加上RAL的疗效。主要目的是比较HIV DNA的数量和轨迹。八十二人被转介。各种各样的原因排除了10人以外的所有人的参加，参加和完成这项研究的人在抗病毒治疗开始时的平均HIV感染持续时间估计为74天。这些组具有相似的基线特征。与联合用药组（0.34？log 10 份/ mL /天相比，RAL组第一阶段血浆HIV RNA衰减更快（0.67？log 10 拷贝/ mL /天）天），p =？0.037。两组之间具有复制能力的病毒的第二阶段HIV RNA衰减，残留病毒血症，细胞相关RNA，HIV DNA，CD4 + T细胞和2LTR环水平没有差异。在进入血浆中的HIV RNA水平高于中值的人群中，随着时间的推移，2LTR圈明显低于进入人群中的HIV RNA水平较低的人群（p =？0.02）。我们的研究结果表明，ART组中与细胞相关的RNA，HIV DNA，具有复制能力病毒的CD4 + T细胞和具有早期HIV的2LTR圈中的应答均一。 2LTR DNA的动力学并不反映ART引发后血浆HIV RNA下降的动力学。

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