ACTG 398: TRIAL OF AMPRENAVIR DUAL PROTEASE INHIBITOR REGIME IN COMBI

ACTG 398：COMBI 中安普那韦双蛋白酶抑制剂方案的试验

• 批准号: 6263826
• 负责人: Richard C. Reichman
• 金额: $ 1.48万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6263826
• 关键词: AIDS therapy; HIV infections; antiAIDS agent; clinical research; combination chemotherapy; human subject; human therapy evaluation; protease inhibitor; reverse transcriptase inhibitors

The protease inhibitor class of drugs is important for the long-term clinical outcome of HIV infected subjects. Given the recognized difficult in achieving virologic suppression in individuals who have been experienced virologic failure, this study has been designed with the purposes of a) providing maximally potent complex regimes utilixing combinations of currently approved protease inhibitors and experimental agents drawn from protease inhibitor (Amprenavir), nucleoside (abacavir), nucleotide (adefovir) and non-nucleoside (efavirenz) reverse transcriptase inhibitor classes of agents; b) investigating the salvage potential of mprenavir in dual protease inhibitor containing regimes; c) determining if the potential for salvage is greater if a moderately liberal definition of virologic failure (ie., 1,000 copies/ml plasms HIV rna) is employed and d) determining if a strict definition of virologic success in the setting of protease inhibitor failure (i.e, achieving plasma HIV-1 rna levels <200 copies per ml) is realistic with the therapeutic agents on the immediate horizon.

蛋白酶抑制剂类药物对HIV感染受试者的长期临床结局很重要。 考虑到在经历病毒学失败的个体中实现病毒学抑制的公认困难，本研究的目的是a）利用目前批准的蛋白酶抑制剂和从蛋白酶抑制剂提取的实验剂的组合提供最大效力的复合方案，（安普那韦），核苷（阿巴卡韦），核苷酸（阿德福韦）和非核苷（依法韦仑）逆转录酶抑制剂类的药剂; B）研究在含有双重蛋白酶抑制剂的方案中，安普那韦的补救潜力; c）确定如果病毒学失败的适度宽松定义（即，1，000拷贝/ml的HIV-1 rna），以及d）确定在蛋白酶抑制剂失效的情况下病毒学成功的严格定义（即，达到血浆HIV-1 rna水平<200拷贝/ml）对于即将出现的治疗剂是否现实。