Study of Pentasa® for Reducing Residual Systemic Immune Activation in Treated HIV Infection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Inflammation markers
研究概览
简要总结
An open label study will be performed on 80 people with HIV infection who are maintained on effective treatment with antiretroviral drugs.
详细描述
The goal of this study is to test whether a bowel anti-inflammatory drug that is known to be safe and effective for inflammatory bowel disease would offer benefit in reducing the residual immune activation associated with treated HIV-1 infection. Specifically, the two immediate goals are to examine the safety of Pentasa® in reducing markers of immune activation believed to be important reflectors of risk for cardiovascular disease and ongoing immune damage in people with chronic treated HIV-1 infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Age at least 18
- •On ART for at least 1 year during which: viremia <50 RNA copies/ml for at least 3 measurements (allowing for 1 nonconsecutive blip of <100), and CD4 T cell count consistently >500 during that time
- •CD4 T cell nadir >350
- •Last CD4 and T cell test in past 6 months
排除标准
- •Plans to modify antiretroviral therapy in the next 12 weeks for any reason
- •History of inflammatory bowel disease or irritable bowel disease
- •Chronic active hepatitis B or C
- •History of autoimmune disease
- •Hypersensitivity to any component of Pentasa
- •Clostridium difficile infection
- •Receiving rectally delivered medications
- •Receiving anti-inflammatory medications (such as nonsteroidal anti- inflammatory drugs, steroids, or TNF inhibitors)
- •Receiving immunosuppressive steroids
- •Receiving any medications associated with bleeding risk
- •Hemoglobin < 10.0 g/dL
- •Platelet count less than 100,000/mm3
- •White blood cell count < 2,000 cells/mm3 or > 15,000 cells/mm3
- •Symptoms of sexually transmitted infection
- •Antibiotics used in the last 90 days
- •Renal insufficiency with creatinine clearance less than 50 ml/min
- •Elevated transaminases greater than 2.5 times the upper limit of normal
- •Evidence of decompensated cirrhosis, heart failure
- •Pregnant or breastfeeding women
研究组 & 干预措施
Pentasa
40 participants will be randomized to take 1 gram of Pentasa, twice daily for 8 weeks
干预措施: Pentasa vs Align (Drug)
Align
40 participants will be randomized to take Align tablets, once daily for 8 weeks
干预措施: Pentasa vs Align (Drug)
结局指标
主要结局
Inflammation markers
时间窗: 14 weeks
C-reactive protein
次要结局
- Plasma markers of microbial translocation(14 weeks)
- Flow cytometry for cellular immune activation(14 weeks)