NCT00052117已完成2 期
A Phase 2, Randomized, Double-Blind, Dose-Ranging Study Of Capravirine (AG1549) In Combination With Kaletra (Trademark) and At Least 2 Nucleoside Reverse Transcriptase Inhibitors in Hiv-Infected Subjects Who Have Failed Antiretroviral Regimens Containing Protease Inhibitors, Nonnucleoside Reverse Transcriptase Inhibitors, and Nucleoside Reverse Transcriptase Inhibitors
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 300
- 主要终点
- To determine the optimal safe and effective dose of capravirine in combination with Kaletra plus at least 2 NRTIs
研究概览
简要总结
This is a 48 week study for HIV-infected patients who have failed several regimens including PI's, NNRTs and NRTIs. Patients will be randomly selected to be in 1 of 4 groups. Three of the 4 groups will contain capravirine in different doses combined with Kaletra and nucleosides and one of the groups will be a combination of Kaletra and nucleosides without the capravirine.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-infected male or female at least 18 years of age
- •HIV RNA level >1000 copies/mL at screening
- •Subject has failed regimens that included at least 1 protease inhibitor but not more than 3 protease inhibitors, at least 1 nonnucleoside reverse transcriptase inhibitor, and least 2 nucleoside reverse transcriptase inhibitors
- •Adequate renal function
- •Adequate hematological function
- •Adequate liver function
排除标准
- •Women who are pregnant or lactating
- •No previous experience with Kaletra
结局指标
主要结局
To determine the optimal safe and effective dose of capravirine in combination with Kaletra plus at least 2 NRTIs
次要结局
- the relationship of HIV baseline resistance (genotype and phenotype) to virologic outcome
- the population pharmacokinetics of capravirine and lopinavir/ritonavir (Kaletra) using mixed-effects modeling
- the pharmacokinetic drug-drug interactions between capravirine and Kaletra and selected concomitant medications
- changes in subject-reported health status and HIV symptoms using the Medical Outcomes Study - HIV Health Survey (MOS-HIV) and the Symptoms Distress Module (National Institute of Allergy and Infectious Diseases Adult AIDS Clinical Trials Group)
研究者
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