A Phase IIIB/IV, Open-label, Multi-center Trial to Evaluate the Safety, Tolerability, and Efficiency of HIV-1 Infected Subjects Switching Their Current Protease-inhibitor Therapies for a Fosamprenavir Therapy Over 48 Weeks

This study was designed to evaluate and compare safety, tolerability of subjects who
successfully suppress HIV-1 on their first PI regimen to those who switch to fosamprenavir.
This is a 48-week study, where subjects who were assigned to be in their original PI-group
have the option of switching to fosamprenavir on week 24. Prior to being assigned their
treatment group, subjects had to be suppressed for at least three months. All subjects also
take a background regimen of two nucleoside/nucleotide reverse transcriptase inhibitors.

本研究旨在评估并对比两类受试者的安全性与耐受性：一类为首次接受蛋白酶抑制剂（Protease Inhibitor，PI）方案且成功抑制HIV-1病毒的受试者，另一类为转换至福沙那韦（fosamprenavir）的受试者。本研究为期48周，被分配至原蛋白酶抑制剂组的受试者可在第24周选择转换至福沙那韦。在被分配至治疗组前，受试者需至少维持HIV-1病毒抑制状态达三个月。所有受试者同时需接受包含两种核苷（酸）类逆转录酶抑制剂的背景治疗方案。