CNAA & B3005:3TC & ZDV & 1592U89 & 3TC & ZDV & IDV IN HIV 1 INFECTED

中国航空航天局

• 批准号: 6309591
• 负责人: NEWTON E HYSLOP
• 金额: $ 1.12万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2000-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6309591
• 关键词: AIDS therapy; HIV infections; antiAIDS agent; clinical research; combination chemotherapy; drug adverse effect; drug interactions; drug screening /evaluation; human subject; human therapy evaluation; indinavir; lamivudine; reverse transcriptase inhibitors; virus RNA; zidovudine

Infection with the human immunodeficiency virus (HIV) is characterized by a progressive decline in immune function, usually over a period of years. For most HIV-1 infected individuals, this decline will eventually result in the development of opportunistic infections (OIs) and/or malignancies associated with the acquired immunodeficiency syndrome (AIDS). Although a long-term AIDS-free survival period may be seen, the majority of individuals will eventually develop AIDS and die as a result of their disease. Currently, treatment for HIV-1 infection consists of antiretroviral chemotherapeutic drugs and the management of the OIs and malignancies associated with AIDS. This is a phase III, randomized double-blind, parallel group, international multicenter study, designed to evaluate the antiviral effect and durability of response (as measured by HIV-1 RNA) and safety of 3TC/ZDV/1592U89 as compared to 3TC/ZDV/IDV. Patients will be evaluated for antiretroviral activity, safety, and tolerance of the treatment regimen.

人类免疫缺陷病毒（HIV）感染的特征是免疫功能进行性下降，通常持续数年。 对于大多数HIV-1感染者，这种下降最终将导致机会性感染（OI）和/或与获得性免疫缺陷综合征（AIDS）相关的恶性肿瘤的发展。 虽然可以看到一个长期的无艾滋病生存期，但大多数人最终会患上艾滋病并因疾病而死亡。 目前，HIV-1感染的治疗包括抗逆转录病毒化疗药物和与AIDS相关的OIs和恶性肿瘤的管理。这是一项III期、随机、双盲、平行组、国际多中心研究，旨在评价3 TC/ZDV/1592 U89与3 TC/ZDV/IDV相比的抗病毒作用和应答持久性（通过HIV-1 RNA测量）以及安全性。将评价患者的抗逆转录病毒活性、安全性和治疗方案的耐受性。