RAD 1: PHASE I & II ANTIRETROVIRAL MANAGEMENT ALGORITHM FOR PEDIATRIC SUBJECTS

目前治疗艾滋病毒感染成人的最新技术是能够将艾滋病毒载量降低到无法检测的水平，这在成人受试者中已经实现，当将逆转录酶抑制剂（RTIs）、核苷类似物（NRTI）或非核苷类似物（NNRTI）与蛋白酶抑制剂（pi）联合使用时。这些受试者中的大多数在24周时表现出HIV病毒载量的显著降低，并且无法检测到HIV RNA。为成人提供的药具通常没有液体配方，或者不适合婴儿、儿童和青少年。本研究为晚期疾病的儿科患者提供抗逆转录病毒药物的联合治疗。该研究旨在确定这些药物是否能使这些晚期患者获益（降低病毒载量；增加CD4细胞）。主要目的：确定当所有抗逆转录病毒药物都改变且至少有2种药物是新型药物时，HIV-1 RNA减少的受试者比例，并确定减少的持续时间。

The current state of the art in treatment of HIV-infected adults is to be able to reduce HIV viral load to non-detectable, which has been achieved in adult subjects when placed on combinations of reverse transcriptase inhibitors (RTIs), nucleoside analogue (NRTI) or non-nucleoside analogue (NNRTI), with protease inhibitors (PIs). The majority of these subjects showed a significant reduction in HIV viral load and had non-detectable HIV RNA at 24 weeks. The armamentarium that exists for adults is often not available in liquid formulation or is non-palatable for infants, children, and adolescents. This study offers combinations of antiretroviral drugs to pediatric subjects with advanced disease. The study is designed to determine whether even these advanced patients can receive benefit (decrease viral load; increase CD4 cells) from these agents. Primary Objective: to determine the proportion of subjects having reduction in HIV-1 RNA when all antiretroviral agents are changed and at least 2 of the agents are novel, and to determine the duration of the reduction.