Enfuvirtide, an HIV-1 fusion inhibitor, for drug-resistant HIV infection in North and South America
Enfuvirtide, an HIV-1 fusion inhibitor, for drug-resistant HIV infection in North and South America
复制标题
DOI：
10.1056/nejmoa035026
复制
发表时间：
2003-05-29
影响因子：
158.5
通讯作者：
Hersch, J
中科院分区：
文献类型：
--
作者：
Lalezari, JP;Henry, K;Hersch, J
背景：T-20与优化方案仅研究1（TORO 1）是一项随机、开放标签、3期恩夫韦肽（T-20）研究，恩夫韦肽是一种人类免疫缺陷病毒1型（HIV-1）融合抑制剂。METHODS：来自美国、加拿大、墨西哥和巴西48个地点的患者，既往接受过3类抗逆转录病毒药物治疗至少6个月，对这些药物耐药，或两者兼有，每毫升血浆中HIV-1 RNA拷贝数至少为5000，以2：1的比例随机分配接受恩夫韦肽加3 - 5种抗逆转录病毒药物的优化背景方案或单独接受这种方案（对照组）。主要疗效终点为血浆HIV-1 RNA水平从基线至第24周的变化。结果：共有501例患者接受随机分组，其中491例接受至少一剂研究药物，并在治疗开始后至少测量一次血浆HIV-1 RNA。两组在基线HIV-1 RNA水平中位数（两组均为5.2 log（sub 10）拷贝/毫升）、CD 4+细胞计数中位数（恩夫韦肽组为75.5个细胞/立方毫米，对照组为87.0个细胞/立方毫米）、人口统计学特征和既往抗逆转录病毒治疗方面平衡。24周时，恩夫韦肽组病毒载量（意向治疗，末次观察值结转）较基线的最小二乘平均变化为每毫升减少1.696 log（sub 10）拷贝，对照组减少0.764 log（sub 10）拷贝（P
BACKGROUND:The T-20 vs. Optimized Regimen Only Study 1 (TORO 1) was a randomized, open-label, phase 3 study of enfuvirtide (T-20), a human immunodeficiency virus type 1 (HIV-1) fusion inhibitor.METHODS:Patients from 48 sites in the United States, Canada, Mexico, and Brazil with at least six months of previous treatment with agents in three classes of antiretroviral drugs, resistance to drugs in these classes, or both, and with at least 5000 copies of HIV-1 RNA per milliliter of plasma were randomly assigned in a 2:1 ratio to receive enfuvirtide plus an optimized background regimen of three to five antiretroviral drugs or such a regimen alone (control group). The primary efficacy end point was the change in the plasma HIV-1 RNA level from base line to week 24.RESULTS:A total of 501 patients underwent randomization, and 491 received at least one dose of study drug and had at least one measurement of plasma HIV-1 RNA after treatment began. The two groups were balanced in terms of the median base-line HIV-1 RNA level (5.2 log(sub 10) copies per milliliter in both groups), median CD4+ cell count (75.5 cells per cubic millimeter in the enfuvirtide group, and 87.0 cells per cubic millimeter in the control group), demographic characteristics, and previous antiretroviral therapy. At 24 weeks, the least-squares mean change from base line in the viral load (intention-to-treat, last observation carried forward) was a decrease of 1.696 log(sub 10) copies per milliliter in the enfuvirtide group, and a decrease of 0.764 log(sub 10) copies per milliliter in the control group (P