Changes in plasma HIV-1 RNA and CD4+ lymphocyte counts and the risk of progression to AIDS
Changes in plasma HIV-1 RNA and CD4+ lymphocyte counts and the risk of progression to AIDS
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DOI：
10.1056/nejm199602153340703
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发表时间：
1996-02-15
影响因子：
158.5
通讯作者：
Egorin, MJ
中科院分区：
文献类型：
--
作者：
OBrien, WA;Hartigan, PM;Egorin, MJ
背景。抗逆转录病毒药物的临床试验可能需要数年时间才能完成，因为测量的结果是进展为获得性免疫缺陷综合症（艾滋病）或死亡。通过使用 CD4+ 淋巴细胞计数的变化以及人类免疫缺陷病毒 1 型 (HIV-1) RNA 和 β(2)-微球蛋白的血浆水平的变化等终点可以加速试验，但这些替代指标是否是疾病进展的有效预测因素尚不确定。我们分析了退伍军人事务部艾滋病合作研究的数据，该研究比较了立即治疗和延迟齐多夫定治疗。测量患者储存血浆中的 HIV-1 RNA 和 β(2)-微球蛋白血浆水平。结果。在立即治疗组的 129 名患者中，有 34 名患者进展为艾滋病，而延迟治疗组的 141 名患者中有 57 名患者进展为艾滋病（P=0.03）。艾滋病进展与基线 CD4+ 淋巴细胞计数 (P=0.001) 和血浆 HIV-1 RNA 水平 (P
Background. Clinical trials of antiretroviral drugs can take years to complete because the outcomes measured are progression to the acquired immunodeficiency syndrome (AIDS) or death. Trials could be accelerated by the use of end points such as changes in CD4+ lymphocyte counts and plasma levels of human immunodeficiency virus type 1 (HIV-1) RNA and beta(2)-microglobulin, but there is uncertainty about whether these surrogate measures are valid predictors of disease progression.Methods. We analyzed data from the Veterans Affairs Cooperative Study on AIDS, which compared immediate with deferred zidovudine therapy. Patients' plasma levels of HIV-1 RNA and beta(2)-microglobulin were measured in stored plasma.Results. Among the 129 patients in the immediate-treatment group, 34 had disease that progressed to AIDS, as compared with 57 of the 141 patients in the deferred-treatment group (P=0.03). Progression to AIDS correlated strongly with base-line CD4+ lymphocyte counts (P=0.001) and plasma levels of HIV-1 RNA (P