SAFETY & EFFICACY OF HYDROXYUREA IN SUBJECTS ON POTENT ANTIRETROVIRAL

该试验将是一项II期、随机、部分盲法研究，评估HU加入强效抗逆转录病毒治疗后对血浆HIV RNA已被抑制至检测水平以下的受试者的安全性和有效性。该研究的主要终点将是病毒抑制的丧失（HIV RNA bb0 200拷贝/mL）或研究药物毒性。399名HIV阳性受试者将被纳入研究。接受IDV、ZDV和3TC治疗至少6个月后血浆HIV RNA < 200拷贝/ml的HIV感染者。ACTG 343受试者目前必须有CD4细胞计数>200细胞/毫米(3)，并且必须在开始他们的IDV/ZDV/3TC方案之前的3个月内有记录的CD4细胞计数>100细胞/毫米(3)。受试者不得有任何ddI、d4T或HU的禁忌症，也不得暴露于除茚那韦以外的蛋白酶抑制剂。受试者将根据参与情况进行分层。

This trial will be a Phase II, randomized, partially-blinded study evaluating the safety and efficacy of HU when added to potent antiretroviral therapy in subjects with plasma HIV RNA already suppressed below the level of detection. The primary endpoints of the study will be loss of viral suppression (HIV RNA > 200 copies/mL) or study drug toxicity. 399 HIV+ subjects will be enrolled in the study. HIV-infected subjects with documented plasma HIV RNA < 200 copies/ml after having received at least 6 months of IDV, ZDV and 3TC. ACTG 343 subjects must currently have a CD4 count >200 cells/mm(3) and must have had a documented CD4 count >100 cells/mm(3) within the 3 months prior to beginning their IDV/ZDV/3TC regimen. Subjects must not have any contraindication to ddI, d4T or HU or have had any exposure to protease inhibitors other than indinavir. Subjects will be stratified by participation.