NCT00477048已完成2 期
Efficacy and Safety of a Saquinavir Based Regimen in HIV-1 Infected Thai Patients Who Have Chronic IDV Associated Nephrotoxicity.
The HIV Netherlands Australia Thailand Research Collaboration1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2004年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Viral load less than 50 copies/ml Improvement of renal functions and renal imaging
研究概览
简要总结
Efficacy and safety of a saquinavir (SQV) based regimen in HIV-1 infected Thai patients who have chronic indinavir (IDV) associated nephrotoxicity.
详细描述
Primary objective:
To determine whether a switch to a SQV can cause improvements in renal function in patients with chronic IDV associated nephrotoxicity without improvement after IDV dose reduction.
Secondary objective:
- To describe the pathophysiology of chronic IDV associated renal impairment through renal biopsies at baseline and week 48
- To describe the pathophysiology of chronic IDV associated renal impairment through renal tubular function at baseline and week 48
- To determine whether a switch to an SQV can cause improvements in renal pathophysiology in patients with chronic IDV associated nephrotoxicity through renal biopsies performed at baseline and at weeks 48
- To determine whether a switch to an SQV results in improvements in hypertension, lipid profiles and cutaneous side effects
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 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IDV containing regimen for more than 1 year and have creatinine more than 1.4 at least 6 months/abnormal renal imaging/abnormal urinary examinations
- •Viral load less than 50 copies
排除标准
- •Saquinavir intolerance
研究组 & 干预措施
1
Other
Replace Indinavir with SQV in patients with indinavir toxicity
干预措施: Saquinavir (Drug)
结局指标
主要结局
Viral load less than 50 copies/ml Improvement of renal functions and renal imaging
时间窗: 48 weeks
次要结局
- Metabolic and cutaneous profile(48 weeks)
研究者
研究点 (1)
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