一项针对未接受过抗病毒治疗的泰国HIV感染患者，比较去羟肌苷加司他夫定与单用去羟肌苷的随机剂量探索性研究。

A randomized, dose-finding study with didanosine plus stavudine versus didanosine alone in antiviral-naive, HIV-infected Thai patients.

作者信息

Ruxrungtham K, Kroon E D, Ungsedhapand C, Teeratakulpisarn S, Ubolyam S, Buranapraditkun S, van Leeuwen R, Weverling G J, Kunanusont C, Lange J M, Cooper D A, Phanuphak P

机构信息

Thai Red Cross AIDS Research Centre, the Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok.

出版信息

AIDS. 2000 Jul 7;14(10):1375-82. doi: 10.1097/00002030-200007070-00010.

DOI:10.1097/00002030-200007070-00010

PMID:10930152

Abstract

OBJECTIVES

To evaluate the safety and efficacy of four different regimens of didanosine (ddI) + stavudine (d4T) in HIV-infected Thais.

DESIGN

Prospective, open-label, randomized study.

METHODS

Patients were randomized to four regimens of high and low doses of ddI and d4T or to ddI alone. D4T was added to the ddI-alone arm after week 24. The duration of study was 48 weeks.

RESULTS

Seventy-eight patients were randomized (mean CD4 cell count, 255 x 10(6)/l; mean plasma HIV-1 RNA; 4.3 log10 copies/ml). In the intent-to-treat analysis, 78% of patients in the pooled combination arms and 20% of the patients in the ddI alone arm (to which d4T was added after 24 weeks) showed plasma HIV-1 RNA < 500 copies/ml at week 24 (P < 0.001), and 59% versus 53% at week 48, respectively. In addition, the proportion of patients with < 50 HIV-1 RNA copies/ml was 13% versus 7% at week 24 (P = 0.5) and 17% versus 20% at week 48 respectively. At week 24, median CD4 cell count increases from baseline were 101 x 10(6)/l in the pooled combination versus 76 x 10(6)/l in the ddI alone arm (P = 0.78). Logistic regression modeling suggested a correlation between receiving high dose ddI and achieving HIV-1 RNA < 500 copies/ml at week 48 (P = 0.07).

CONCLUSIONS

The d4T/ddI combination was superior to ddI alone in producing HIV-1 viral suppression. At week 48, > 60% of patients treated with this combination reached HIV-1 RNA levels < 500 copies/ml. Receiving high dose ddI but not d4T may correlate with a better viral suppression.

摘要

目的

评估四种不同的去羟肌苷（ddI）+司他夫定（d4T）治疗方案对泰国HIV感染者的安全性和疗效。

设计

前瞻性、开放标签、随机研究。

方法

患者被随机分为四种高低剂量ddI和d4T联合方案组或单独使用ddI组。单独使用ddI组在第24周后加用d4T。研究持续时间为48周。

结果

78例患者被随机分组（平均CD4细胞计数，255×10⁶/l；平均血浆HIV-1 RNA；4.3 log₁₀拷贝/ml）。在意向性分析中，联合用药组78%的患者和单独使用ddI组（24周后加用d4T）20%的患者在第24周时血浆HIV-1 RNA<500拷贝/ml（P<0.001），在第48周时分别为59%和53%。此外，HIV-1 RNA拷贝/ml<50的患者比例在第24周时分别为13%和7%（P = 0.5），在第48周时分别为17%和20%。在第24周时，联合用药组CD4细胞计数中位数较基线增加101×10⁶/l，单独使用ddI组为76×10⁶/l（P = 0.78）。逻辑回归模型表明，接受高剂量ddI与在第48周时HIV-1 RNA<500拷贝/ml之间存在相关性（P = 0.07）。