Stavudine in patients with AIDS and AIDS-related complex: AIDS clinical trials group 089.

Stavudine in patients with AIDS and AIDS-related complex: AIDS clinical trials group 089.
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司他夫定治疗艾滋病和艾滋病相关综合症患者:艾滋病临床试验组 089。

DOI:
10.1093/infdis/171.supplement_2.s123
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发表时间:
1995
期刊:
The Journal of infectious diseases
影响因子:
--
通讯作者:
Dunkle,LM
Dunkle,LM
中科院分区:
--
文献类型:
--
作者:
Murray,HW;Squires,KE;Weiss,W;Sledz,S;Sacks,HS;Hassett,J;Cross,A;Anderson,RE;Dunkle,LM

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在司他夫定治疗艾滋病或艾滋病相关复合体(ARC)的I期试验中,41名患者接受了剂量为0.5-12.0 mg/kg/d的抗病毒效果和安全性评估。在可评估的患者中,40名患者中有24名(60%)在治疗期间保持了10%的CD4淋巴细胞计数增加;34名患者中有31名(91%)在10周时观察到NAVC应答(CD4细胞计数-时间曲线下的归一化面积>1.0);在24周时,25名患者中有20名(80%)观察到NAVC反应;18名患者中有15名(83%)p24抗原血症下降;40名患者中有24名(60%)体重增加了2.5公斤。接受安慰剂0.5rug/kg/天的患者6个月中,CD4淋巴细胞水平中位数保持在基线水平以上。在有p24抗原应答的患者中,血清p24抗原水平的中位数在一年内保持在基线以下。主要的毒性是周围神经病变,一般在停药后症状消失,但将剂量限制在2.0卢格/公斤/天。评估司他夫定对总体发病率和死亡率影响的其他试验正在进行中。
In a phase I trial of stavudine in AIDS or AIDS-related complex (ARC), antiviral effects and safety were assessed in 41 patients treated with dosages of 0.5–12.0 mg/kg/day. Among evaluable patients, 10% increases in CD4lymphocyte counts were sustained in 24 (60%) of 40 during treatment; anNAVCresponse (normalized area under the CD4 cell count-versus-time curve > 1.0) was observed in 31 (91 %) of 34 at 10 weeks and in 20 (80%) of 25 at 24 weeks; 15 (83%) of 18 had decreases in p24 antigenemia; and 24 (60%) of 40 gained >2.5 kg body weight. Median CD4lymphocyte levels remained above baseline for 6 months in patients receiving >0.5 rug/kg/day. Median serum p24 antigen levels remained below baseline for >1 year in patients with p24 antigen responses. The principal toxicity was peripheral neuropathy, which generally resolved after drug discontinuation but limited the dosage to <2.0 rug/kg/day. Additional trials assessing the effect of stavudine on overall morbidity and mortality are ongoing.
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