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临床试验/NCT00477048
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:

  1. To describe the pathophysiology of chronic IDV associated renal impairment through renal biopsies at baseline and week 48
  2. To describe the pathophysiology of chronic IDV associated renal impairment through renal tubular function at baseline and week 48
  3. 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
  4. 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

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

申办方类型
Other
责任方
Sponsor

研究点 (1)

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