Kazatchkine M D, Van P N, Costagliola D, Mohammed A S, Ledeine J M, Troccaz M, Belec L
Service d'Immunologie, Hôpital Broussais, Paris, France.
J Acquir Immune Defic Syndr. 2000 Aug 15;24(5):418-24. doi: 10.1097/00126334-200008150-00003.
To compare the antiviral activity, effect on CD4 cell count, and tolerability of didanosine (ddI) administered once daily and twice daily in HIV-1-infected patients receiving ddI with stavudine or zidovudine, with or without a protease inhibitor. The study was designed to demonstrate that once-daily dosing of ddI was not inferior to twice-daily dosing.
Randomized, open-label, multicenter, two-arm study.
121 HIV-1-infected adults on a stable regimen including ddI (twice daily) during the previous 3 months with a stable viral load <10,000 copies/ml started therapy. Of these, 62 were randomized to switch to a combination that included ddI once daily and 59 to continue with ddI twice daily. The ddI dose was 400 mg/day (250 mg/day if body weight was <60 kg). The primary efficacy analysis compared the time-averaged difference (TAD) between the two treatment regimens in change from baseline log10 plasma HIV-1 RNA levels over 24 weeks of therapy, with an equivalence margin between the two treatment groups of <0.5 log10 copies/ml.
At week 24, the mean plasma HIV-1 RNA level had increased by 0.31 and 0.17 log10 copies/ml in the ddI once-daily and ddI twice-daily groups, respectively. The time-averaged difference between the two groups in change from baseline plasma HIV-1 RNA levels over 24 weeks was (0.05 log10 copies/ml (95% confidence interval, -0.21 to +0.12 log10 copies/ml), indicating that the antiviral activity of ddI once daily is similar to that of ddI twice daily. After 24 weeks of treatment, changes from baseline in CD4 cell counts were similar in the two groups. Both regimens were generally well-tolerated.
Once-daily and twice-daily ddI are equally effective at reducing plasma HIV-1 RNA levels when used in a combination regimen with stavudine or zidovudine, with or without a protease inhibitor.
比较在接受去羟肌苷（ddI）与司他夫定或齐多夫定联合治疗（加或不加蛋白酶抑制剂）的HIV-1感染患者中，每日一次和每日两次服用去羟肌苷（ddI）的抗病毒活性、对CD4细胞计数的影响及耐受性。该研究旨在证明每日一次服用ddI并不劣于每日两次服用。
随机、开放标签、多中心、双臂研究。
121名HIV-1感染的成年人，在前3个月采用包括ddI（每日两次）的稳定治疗方案，病毒载量稳定<10,000拷贝/毫升，开始治疗。其中，62人随机改为包含每日一次ddI的联合治疗方案，59人继续每日两次服用ddI。ddI剂量为400毫克/天（体重<60千克者为250毫克/天）。主要疗效分析比较了两种治疗方案在治疗24周期间血浆HIV-1 RNA水平相对于基线log10变化的时间平均差异（TAD），两个治疗组之间的等效界值<0.5 log10拷贝/毫升。
在第24周时，每日一次ddI组和每日两次ddI组的血浆HIV-1 RNA平均水平分别升高了0.31和0.17 log10拷贝/毫升。两组在24周期间相对于基线血浆HIV-1 RNA水平变化的时间平均差异为0.05 log10拷贝/毫升（95%置信区间，-0.21至+0.12 log10拷贝/毫升），表明每日一次ddI的抗病毒活性与每日两次ddI相似。治疗24周后，两组CD4细胞计数相对于基线的变化相似。两种治疗方案总体耐受性良好。
当与司他夫定或齐多夫定联合使用（加或不加蛋白酶抑制剂）时，每日一次和每日两次服用ddI在降低血浆HIV-1 RNA水平方面同样有效。
