Pilot Study of Raltegravir Switch to Resolve Tenofovir Induced Proteinuria (RALPIR)
A Pilot Study to Evaluate the Effectiveness of a Tenofovir Raltegravir Switch in Resolving Tenofovir Induced Proteinuria in HIV Infected Individuals With Undetectable HIV Viral Loads
The study is designed to evaluate the proportion of patients with tenofovir induced proteinuria that will resolve their proteinuria when the tenofovir containing nucleoside/nucleotide backbone is switched to a raltegravir backbone. Common HIV treatment regimens contain nucleoside/nucleotide combinations that may have long-term side effects including nephrotoxicity. Switching these backbones out for an integrase inhibitor based regimen has not been systematically evaluated.
Hypothesis: Proteinuria developing during treatment with tenofovir improves or resolves when tenofovir is switched out with raltegravir. Switching to a nuc- sparing regimen, containing raltegravir and a boosted protease inhibitor in patients without preexisting protease inhibitor mutations is safe and does not lead to virologic failure
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Documented HIV infection
- Ability to comply to protocol requirements
- On stable HAART for minimum of 12 weeks
- Evidence of TDF induced proteinuria
- No evidence of prior Protease inhibitor failure
- Treatment-naïve to integrase inhibitors
- VL<200 x 12 weeks (minimum of 2 viral load measurements)
Exclusion Criteria:
- Active Hepatitis B infection
- Proteinuria predating tenofovir use
- PRAMs on historic GT or PT
- Life expectancy less than 6 months
- Subjects with any ongoing AIDS defining illness
- Any condition which could compromise the safety of study subject
- Grade 3 or 4 lab abnormalities (excl. grade 3 bilirubin elevations)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：change from tenofovir to raltegravir
Single arm study: Tenofovir containing nucleoside backbone changed over to raltegravir in all patients |
Change of the tenofovir based nucleoside part of the HIV regimen to raltegravir, 400mg BID
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patients With Reduced or Resolved Proteinuria
大体时间：24 weeks
|
Measurement of Protein in Urine samples at end of study visit
|
24 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patients Without HIV Re-bound
大体时间：24 weeks
|
HIV Viral load blood test at week 24
|
24 weeks
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.