T 20 ADMINISTERED TO HIV 1 ADULTS BY CONTINUOUS SUBCUTANEOUS INFUSION

在这项第二阶段研究中，主要参数是临床和实验室安全性数据，以及T-20单次给药和达到稳定状态后的血浆AUC和Cmax。病毒RNA分析和免疫表型鉴定小组的结果将被视为次要终点。研究试剂T-20是一个由36个氨基酸组成的合成肽。T-20是由自然产生的I-氨基酸残基组成的线性分子。非临床作用机制研究结果表明，T-20通过与调节病毒与宿主细胞膜融合的gp41关键区域的结合，显示出对新生感染和细胞间病毒传播的有效和选择性的抑制。研究试剂T-20是一个由36个氨基酸组成的合成肽。到目前为止，T-20已经在16名HIV-1阳性志愿者中进行了I期多剂量逐步递增研究。结果表明，没有证据表明T-20的急性临床或实验室毒性与使用T-20有关。在这项初步研究中观察到T-20的抗逆转录病毒作用呈剂量依赖性。

In this Phase II study the primary parameters are clinical and laboratory safety data and the plasma AUC and Cmax for T-20 when administered as a single dose and after steady state has been achieved. Viral RNA assays and the immunophenotyping panel results will be regarded as secondary endpoints. The investigational agent, T-20, is a 36-amino acid synthetic peptide. T-20 is a linear molecule composed of naturally-occurring I-amino acid residues. The results of nonclinical mechanism of action studies indicate that T-20 exhibits potent and selective inhibition of de novo infection and cell to cell virus transmission by binding to a critical region of gp41 which regulates the fusion of virus to host cell membranes. The investigational agent, T-20, is a 36-amino acid synthetic peptide. T-20 thus far has been studied in 16 HIV-1 positive volunteers in a Phase I multi-dose dose escalation study. Results indicate that no evidence of acute clinical or laboratory toxicity was associated with the administration of T-20. There was a dose-dependent antiretroviral effect of T-20 observed in this initial study.