NL-OMON38097已完成3 期
A Phase III Randomized, Double-blind Study of the Safety and Efficacy of GSK1349572 50 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Both Administered with an Investigator-selected Background Regimen Over 48 Weeks in HIV-1 Infected, Integrase Inhibitor-Naïve, Antiretroviral Therapy-Experienced Adults. - N/A
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* HIV-1 infected subjects *18 years of age.
- •* HIV-1 infection as documented by HIV-1 RNA >400 c/mL.
- •* Documented resistance to two or more different classes of antiretroviral agents.
- •* Integrase inhibitor-naïve.
- •* Safe contraception for women of childbearing potential.
排除标准
- •* Screening resistance test result indicates no fully active antiviral agents are available for design of the background regimen.
- •* Subject-virus is not evaluable using genotype/phenotype/tropism.
- •* Breastfeeding, pregnancy.
- •* Any evidence of an active Center for Disease and Prevention Control (CDC) Category C disease [CDC, 1993], except cutaneous Kaposi*s sarcoma not requiring systemic therapy or historic or current CD4+ cell count <200 cells/mm3 are not exclusionary.
- •* History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma.
- •* Treatment with any of the following agents within 28 days of Screening: radiation, cytotoxic chemotherapeutic agents, immunomodulators.
研究者
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