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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Patients With Reduced or Resolved Proteinuria
研究概览
简要总结
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
详细描述
As described in the brief summary, this is a pilot study to evaluate for improvements in proteinuria when switched off from Tenofovir
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
- •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)
排除标准
- •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)
研究组 & 干预措施
change from tenofovir to raltegravir
Single arm study:
Tenofovir containing nucleoside backbone changed over to raltegravir in all patients
干预措施: change from tenofovir to raltegravir (Drug)
结局指标
主要结局
Patients With Reduced or Resolved Proteinuria
时间窗: 24 weeks
Measurement of Protein in Urine samples at end of study visit
次要结局
- Patients Without HIV Re-bound(24 weeks)
研究者
Fritz Bredeek, MD, PhD
President
Metropolis Medical