NCT00298350已完成2 期
Phase 2 Study of the Treatment of Antiretroviral Treatment-Experienced Subjects Comparing Ritonavir-Boosted GS-9137 (GS-9137/r) vs. a Comparator Ritonavir-Boosted Protease Inhibitor (CPI/r) in Combination With Background ART.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 278
- 试验地点
- 54
研究概览
简要总结
The purpose of this study is to evaluate the non-inferiority of ritonavir-boosted GS-9137 relative to a ritonavir-boosted Comparator Protease Inhibitor when used as part of combination antiretroviral regimens in subjects who have failed, or are failing, protease inhibitor therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV RNA greater than or equal to 1000 c/mL.
- •Failed/Failing protease inhibitor based antiretroviral therapy.
- •Stable antiretroviral therapy for greater than or equal to 30 days prior to screening.
- •Negative Serum Pregnancy Test.
- •GFR by Cockcroft Gault greater than or equal to 80 mL/min.
- •AST & ALT less than or equal to 2.5x ULN.
- •Total Bilirubin less than or equal to 1.5 mg/dL.
- •Albumin greater than 3.5 mg/dL.
- •Prothrombin Time INR 1.0-1.4
- •Platelets greater than or equal to 50,
- •Hemoglobin greater than or equal to 8.0 mg/dL.
- •Absolute Neutrophil Count greater than or equal to 1000.
排除标准
- •New AIDS defining condition within 30 days of baseline.
- •Prior treatment with HIV-1 integrase inhibitor (except patients from 183-101).
- •Ascites or encephalopathy.
- •Breast Feeding.
- •Cancer Diagnosis (besides Kaposi Sarcoma or Basal Cell Carcinoma).
研究者
研究点 (54)
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