SAFETY & EFFICACY OF HYDROXYUREA IN SUBJECTS ON POTENT ANTIRETROVIRAL

安全

• 批准号: 6265144
• 负责人: MD MICHAEL FRANK
• 金额: $ 0.04万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 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/6265144
• 关键词: AIDS therapy; HIV infections; antiAIDS agent; clinical research; combination chemotherapy; human subject; human therapy evaluation; hydroxyurea; indinavir; lamivudine; zidovudine

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.

本试验将是一项II期、随机、部分设盲研究，旨在评价在血浆HIV RNA已抑制至检测水平以下的受试者中，将HU添加至强效抗逆转录病毒治疗时的安全性和疗效。 该研究的主要终点将是病毒抑制的丧失（HIV RNA > 200拷贝/mL）或研究药物毒性。本研究将入组399例HIV+受试者。 接受IDV、ZDV和3 TC治疗至少6个月后，记录血浆HIV RNA < 200拷贝/ml的HIV感染受试者。 ACTG 343受试者目前必须有CD 4计数>200个细胞/mm（3），并且必须在开始IDV/ZDV/3 TC方案前3个月内有记录的CD 4计数>100个细胞/mm（3）。 受试者不得有任何ddI、d4 T或HU禁忌症或暴露于除茚地那韦以外的蛋白酶抑制剂。受试者将按参与情况分层。