一项随机试验来评估延续与拉米夫定停药的个人失败lamivudine-containing方案:COLATE试验。
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福克斯Z, Dragsted乌兰巴托,Gerstoft J,菲利普斯,·卡亚尔:J, Mathiesen L, Youle M, Katlama C,希尔,Bruun约,Clumeck N, Dellamonica P Lundgren JD
一项随机试验来评估延续与拉米夫定停药的个人失败lamivudine-containing方案:COLATE试验。
小红伞。2006;11 (6):761 - 70。
- PubMed ID
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17310820 (在PubMed]
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背景:拉米夫定(3 tc)治疗可引起M1841 / V的出现。先前的研究表明更高的保真度的突变逆转录酶和更低的突变病毒的复制能力。没有数据存在的临床比较研究评估的好处M1841 / V在患者接受抗逆转录病毒疗法(cART)组合。方法:成人HIV-1-infected失败3 tc-containing方案随机继续(On-3TC)或中止3 tc (Off-3TC)同时接受车。主要疗效测量是log10 average-area-under-the-curve-minus-baseline减少艾滋病毒RNA在48周。低温贮藏>基线患者血浆样本或= 1后续示例与艾滋病毒RNA > 500拷贝/毫升核苷酸距离substudy测序。进化距离比较治疗手臂和病毒之间有或没有M1841 / V。结果:48周总的log10 HIV RNA变化为-1.4(95%置信区间CI: -1.6、-1.1) On-3TC (n = 65)和-1.5(95%置信区间CI: -1.7、-1.2) Off-3TC (n = 66;P = 0.51)。在无差异的大小CD4 + t细胞计数增加(增加中位数:87 vs 76细胞/毫升3 tc vs Off-3TC,分别)。 Thirty-seven patients had baseline and follow-up sequencing. Overall, there were 1.2 (95% CI: -2.2, 4.6) more nucleotide substitutions from baseline for Off-3TC patients (P=0.50), and 10.7 (95% CI: 7.5, 14.0) fewer nucleotide changes in viruses containing M18411V (P<0.0001). CONCLUSION: This study found no added virological or immunological benefit of continuing 3TC in patients on cART harbouring M1841/V. Evolutionary distances from baseline were larger in viruses that did not contain M1841/V. More discernable benefits may be seen in patients with fewer drug options as potent cART may eclipse a benefit of M1841/V in COLATE.
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