Dormont J, Aboulker J P
Service de médecine interne et de réanimation, hôpital Antoine-Béclère, Clamart.
Rev Prat. 1994 Jun 15;44(12):1635-42.
Antiretroviral drugs already registered or currently in clinical trials are shortly described, including dideoxynucleosides, non-nucleoside reverse transcriptase inhibitors, protease inhibitors, tat inhibitors and antisens molecules. In a second part, the treatment of patients with the nucleosides already on the market or in a pre-registration phase is reviewed, on the basis of an analysis of available phase III clinical trials. The third part describes the strategy of clinical trials and explains why "surrogate markers" including markers of viral replication cannot yet be the main criteria to evaluate the efficacy of a new drug in a phase III trial.
本文简要介绍了已注册或正在进行临床试验的抗逆转录病毒药物,包括双脱氧核苷、非核苷逆转录酶抑制剂、蛋白酶抑制剂、tat抑制剂和反义分子。第二部分在对现有III期临床试验进行分析的基础上,综述了已上市或处于预注册阶段的核苷类药物对患者的治疗情况。第三部分描述了临床试验策略,并解释了为何包括病毒复制标志物在内的“替代标志物”尚不能作为III期试验中评估新药疗效的主要标准。