Pilot Study of Raltegravir Augmentation on Persistent Central Nervous System (CNS) Immunoactivation in Treated HIV-1 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in CSF Concentrations of Neopterin After 12 Weeks
研究概览
简要总结
This pilot study focuses on the persistence of central nervous system (CNS) immune activation that has been observed in the presence of 'effective' combination antiretroviral therapy (cART). Attention to this issue is based on the fear that chronic CNS immunoactivation can cause indolent brain injury that will eventually compromise brain function as patients survive for years on treatment. A leading hypothesis explaining this continued immunoactivation is that viral replication continues within the brain at a level too low for detection in cerebrospinal fluid (CSF), yet sufficient to stimulate local immunoactivation. Based on this hypothesis, we propose to use augmented treatment with raltegravir to test whether additional suppression of this hypothesized CNS HIV-1 replication will reduce continued CNS immunoactivation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Capacity to provide informed consent.
- •Documented HIV-1 infection.
- •History of continuous cART treatment (with at least three drugs) for at least 2 years.
- •Documentation of 'undetectable' plasma HIV-1 RNA for at least 1 year.
- •HIV-1 RNA <50 copies/mL in plasma and CSF at screening visit.
排除标准
- •Contraindication to LP (suspicion of CNS mass lesion, bleeding diathesis, etc.).
- •Prior experience with raltegravir or contraindication to raltegravir treatment, including medication interactions that might compromise ongoing antiretroviral therapy or treatment of other conditions.
- •Active opportunistic infections or neurological diseases.
- •Other conditions or treatments likely to interfere with treatment or evaluation.
- •Hemoglobin < 10 Gm/dL.
- •Pregnant or anticipating pregnancy during study.
- •Active substance abuse.
- •Subjects taking rifampin, phenytoin, Phenobarbital or other drugs that accelerate raltegravir metabolism and might decrease its tissue concentrations.
研究组 & 干预措施
raltegravir group
The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
干预措施: raltegravir (Drug)
结局指标
主要结局
Change in CSF Concentrations of Neopterin After 12 Weeks
时间窗: three months (Rollover subjects were assessed for a second baseline after the initial 12 week period)
CSF markers of immuno¬activation and inflammation after 12 weeks compared to baseline.
次要结局
- Change From Baseline in CD8+ T Cell Co-expression of CD38 and HLA-DR(three months (Rollover subjects were assessed for a second baseline after the initial 12 week period))