NCT00234975已完成4 期
Evaluation of Clinical Response and Safety in HIV Positive Subjects Co-infected With Hepatitis C Treated With a Kaletra Containing HAART Regimen
AbbVie (prior sponsor, Abbott)11 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2002年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 11
- 主要终点
- Primary Outcome Measure
研究概览
简要总结
The purpose of this study is to evaluate clinical response and safety of a Kaletra containing antiretroviral treatment regimen in HIV positive subjects with HCV coinfection.
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
- None
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
- •Documented HIV positive.
- •At least 18 years of age.
- •Does not exhibit evidence of acute illness (especially any acute liver disease, except hepatitis C)
- •Subject has not been treated for an active opportunistic infection within 30 days of the baseline visit.
- •Subject Has a Karnofsky Score greater than or equal to
- •Subject does not require and agrees not to take, for the duration of the study, any of the following medications that are contraindicated with Kaletra: astemizole, terfenadine, midazolam, triazolam, cisapride, certain ergot derivatives (ergotamine, dihydroergotamine, ergonovine, and methylergonovine), pimozide, propafenone and flecainide. Rifampin, a potent enzyme inducer, should not be administered with the study medication, because of the possibility of significant decreases in Kaletra concentration during concurrent administration.
- •The subject agrees not to take any medication, including over-the-counter medicine, alcohol, recreational drugs or herbal preparations without the knowledge and permission of the principal investigator.
- •Subject had laboratory testing within the previous three months and the most recent testing demonstrates all of the following: Hemoglobin> 8.0 g/dL; absolute neutrophil count > 750 cells/mL; Platelet count > 20,000/mL; ALT or AST </=10 x upper limit of normal (ULN); Creatinine< 1.5 x ULN; Triglycerides </=750 mg/dL.
- •Subjects have no evidence of grade III or IV adverse event or laboratory abnormality (except for LFTs).
排除标准
- •No exclusion criteria.
研究组 & 干预措施
HCV +
Active Comparator
干预措施: Lopinavir/Ritonavir (Drug)
HCV -
Active Comparator
干预措施: Lopinavir/Ritonavir (Drug)
结局指标
主要结局
Primary Outcome Measure
时间窗: Baseline, Week 4, Week 8, Week 16 and Week 24
Changes in liver functions enzyme.
次要结局
- Secondary Outcome Measures(Baseline, Week 4, Week 8, Week 16 and Week 24)
研究者
研究点 (11)
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