Response to lamivudine-zidovudine plus abacavir twice daily in antiretroviral-naive, incarcerated patients with HIV infection taking directly observed treatment
Response to lamivudine-zidovudine plus abacavir twice daily in antiretroviral-naive, incarcerated patients with HIV infection taking directly observed treatment
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DOI：
10.1086/338400
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发表时间：
2002-02-15
影响因子：
11.8
通讯作者：
Hernandez, JE
中科院分区：
文献类型：
--
作者：
Kirkland, LR;Fischl, MA;Hernandez, JE
由于许多联合抗逆转录病毒治疗方案的复杂性和侵入性，感染人类免疫缺陷病毒 (HIV) 的监狱囚犯可能难以治疗。 NZTA4007 是一项为期 24 周的开放标签、单组临床试验，涉及 108 名未接受过抗逆转录病毒治疗、被监禁的 HIV 感染者，旨在评估紧凑方案（每天 4 片），该方案由 1 片拉米夫定-齐多夫定（150 mg/300 mg）组合片剂（COM）和 1 片 300 mg 阿巴卡韦片剂组成，在直接观察的治疗条件下每天两次给药。在意向治疗观察分析中，85% 的患者血浆 HIV 1 型 (HIV-1) RNA 水平保持在小于或等于 400 拷贝/mL，并且处于 ! 75% 的患者为 50 拷贝/mL。 HIV-1 RNA 水平相对于基线的中位变化为 -2.41 log(10) 拷贝/mL，CD4 细胞计数为 +111 个细胞/mm(3)。仍然参加该研究的患者对处方剂量的总体依从率为 94%。每日两次服用 COM-阿巴卡韦通常耐受性良好，不良事件仅促使 4 名患者退出研究。
Prison inmates with human immunodeficiency virus (HIV) infection can be difficult to treat because of the complexity and intrusiveness of many combination antiretroviral therapy regimens. NZTA4007, a 24-week open-label, single-arm clinical trial involving 108 antiretroviral therapy-naive, incarcerated, HIV-infected persons, was conducted to evaluate a compact regimen (4 tablets per day) consisting of 1 lamivudine-zidovudine (150 mg/300 mg) combination tablet (COM) and one 300-mg abacavir tablet administered twice daily under directly observed treatment conditions. In the intent-to-treat observed analysis, the plasma HIV type 1 (HIV-1) RNA level remained at less than or equal to400 copies/mL in 85% of the patients and at ! 50 copies/mL in 75% of the patients. Median change from baseline was -2.41 log(10) copies/mL for the HIV-1 RNA level and +111 cells/mm(3) for the CD4 cell count. The overall adherence to prescribed doses was 94% for patients who remained enrolled in the study. COM-abacavir given twice daily was generally well tolerated, and adverse events prompted only 4 patients to withdraw from the study.