NCT00981318终止4 期
Pilot Assessment of Lopinavir/Ritonavir and Maraviroc in Experienced Patients
Rodwick, Barry M., M.D.1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2009年12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
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Virologic response defined as viral load reduction of >/= 1 log
研究概览
简要总结
This is a study to assess the response of lopinavir/ritonavir plus maraviroc (with no nucleoside medications) in HIV patients failing their initial antiviral therapy.
详细描述
As long-term toxicity to many of the nucleoside medications have become known, interest has increased in treatment regimens that do not use these medications. This study is to assess the response of one such "nucleoside-sparing" therapy in patients who are showing failure to their initial nucleoside-containing treatment regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •HIV viral load > 1,000 on current antiviral medications
- •No resistance to study medications
- •Over 18 years of age
排除标准
- •Hepatitis B co-infection
- •Pregnancy
- •Previous therapy with either of the study medications
- •Ongoing substance abuse
- •Significant history of other physical disease
研究组 & 干预措施
lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid
Other
single arm
干预措施: lopinavir/ritonavir plus maraviroc (Drug)
结局指标
主要结局
Virologic response defined as viral load reduction of >/= 1 log
时间窗: 48 weeks
次要结局
- Assess proportion of patients with HIV-1 viral load < 48 copies(48 weks)
- Assess time to loss of virologic response(48 weeks)
- Assess development of resistance mutations in patients who develop rebound(48 weeks)
- Compare serum lipid profile changes(48 weeks)
- Assess safety and tolerability(48 weeks)
- Assess degree of immune reconstitution(48 weeks)
研究者
Barry M. Rodwick, M. D.
Principal Investigator
Rodwick, Barry M., M.D.
研究点 (1)
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