Molina J M, Chêuc G, Ferchal F, Journot V, Pellegrin I, Sombardier M N, Rancinan C, Cotte L, Madelaine I, Debord T, Decazes J M
Department of Infectious Diseases, Saint Louis Hospital, Paris, France.
Antivir Ther. 1999;4 Suppl 3:71-4.
In the ALBI trial, 151 antiretroviral-naive patients with plasma human immunodeficiency virus type 1 (HIV-1) RNA levels of 10,000 to 100,000 copies/ml and CD4 cell counts > or = 200 cells/mm3 received 24 weeks of treatment with stavudine/didanosine (n=51), zidovudine/lamivudine (n=51) or stavudine/didanosine for 12 weeks followed by zidovudine/lamivudine (n=49). Baseline plasma HIV-1 RNA and CD4 cell counts were comparable in the treatment groups. The mean decrease in plasma HIV-1 RNA at 24 weeks in the stavudine/didanosine group (2.26 log10) was significantly greater than that in either the zidovudine/lamivudine group (1.26 log10) or the alternating treatment group (1.58 log10) (P<0.0001 for both). Proportions of patients with plasma HIV-1 RNA level <500 copies/ml (91% vs 42% and 60%) and <50 copies/ml (47% versus 4% and 9%) were significantly greater in the stavudine/didanosine group (P<0.001 for pairwise comparisons). Stavudine/didanosine was associated with a mean increase in CD4 cell count (124 cells/mm3) significantly greater than that in the zidovudine/lamivudine group (62 cells/mm3, P<0.01) and comparable to that in the alternating group (118 cells/mm3). All study regimens were well tolerated. These findings, indicating superiority of stavudine/didanosine over zidovudine/lamivudine in virological and immunological response over 24 weeks, suggest that the combination should be considered as a basis for highly active antiretroviral therapy.
在ALBI试验中，151例初治的血浆人类免疫缺陷病毒1型（HIV-1）RNA水平为10,000至100,000拷贝/毫升且CD4细胞计数≥200个细胞/立方毫米的患者接受了司他夫定/去羟肌苷治疗24周（n = 51）、齐多夫定/拉米夫定治疗24周（n = 51）或司他夫定/去羟肌苷治疗12周后改为齐多夫定/拉米夫定治疗（n = 49）。各治疗组的基线血浆HIV-1 RNA和CD4细胞计数具有可比性。司他夫定/去羟肌苷组在24周时血浆HIV-1 RNA的平均下降幅度（2.26 log10）显著大于齐多夫定/拉米夫定组（1.26 log10）或交替治疗组（1.58 log10）（两者P均<0.0001）。血浆HIV-1 RNA水平<500拷贝/毫升（91%对42%和60%）和<50拷贝/毫升（47%对4%和9%）的患者比例在司他夫定/去羟肌苷组显著更高（两两比较P<0.001）。司他夫定/去羟肌苷与CD4细胞计数的平均增加（124个细胞/立方毫米）相关，显著大于齐多夫定/拉米夫定组（62个细胞/立方毫米，P<0.01），且与交替治疗组（118个细胞/立方毫米）相当。所有研究方案耐受性良好。这些结果表明，在24周的病毒学和免疫学反应方面，司他夫定/去羟肌苷优于齐多夫定/拉米夫定，提示该联合用药应被视为高效抗逆转录病毒治疗的基础。
