Randomized Placebo-controlled Trial of Rosuvastatin in HIV-Infected Subjects to Modulate Cardiovascular Risk and Inflammation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Bone Mineral Density (BMD)
研究概览
简要总结
The hypothesis of this study is that 96 weeks of Rosuvastatin will be safe and effective in decreasing cardiovascular risk and bone loss in the HIV+ population.
详细描述
While the use of antiretroviral therapy (ART) in recent years has had an impressive impact on mortality and disease progression in HIV-infected patients, nevertheless, cardiovascular disease is a major concern impacting morbidity and mortality in this population.
This study will assess if a potent statin, rosuvastatin, could improve endothelial dysfunction, slow carotid intima media thickness (IMT) progression and bone loss, and decrease inflammation and oxidative stress in HIV-infected ART-treated subjects with good HIV virologic control. The investigators will also see if rosuvastatin will induce beneficial changes in the prevalence of metabolic syndrome and lipid metabolism as well as improve bone turnover markers.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Clinical diagnosis of HIV Disease
- •Age > 18 years old
- •Receiving a stable ARV regimen for at least the last 12 weeks prior to study entry and cumulative duration of ARV for 12 months
- •Fasting LDL cholesterol < 130 mg/dl
- •Fasting triglycerides < 300 mg/dL
- •hsCRP > 2 mg/L or CD38+DR+/CD8+ > 19%
- •If on Vit D replacement therapy, stable regimen for > 3 months prior to study entry
排除标准
- •Women who are pregnant or breast feeding
- •Any active or chronic inflammatory condition
- •Cardiovascular disease
- •Current or recent (within 24 weeks of study entry) therapy with omega-3 fatty acids, fibrates, ezetimibe or statins
- •Uncontrolled hypothyroidism or hyperthyroidism
- •Uncontrolled diabetes
- •Use of systemic cancer chemotherapy of immunomodulating agents
- •Use of Anabolic agents, growth hormone, growth hormone releasing factor, or any other anabolic agents, except for stable replacement testosterone.
- •Use of biphosphonates or other bone therapies
- •Any of the following lab findings obtained within 14 days prior to the screening evaluation including the following:
- •AST and/or ALT > 2.5 x ULN
- •Hemoglobin < 9.0 g/dL
- •CK > 3 X ULN
- •Calculated creatinine clearance < 50 mL/min
研究组 & 干预措施
Rosuvastatin
Participants will take Rosuvastatin 10 mg. daily for 96 weeks
干预措施: Rosuvastatin 10 mg. daily for 96 weeks (Drug)
Sugar Pill placebo
Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.
干预措施: Placebo (Drug)
结局指标
主要结局
Bone Mineral Density (BMD)
时间窗: 96 weeks
Measured by change in bone DEXA from baseline to week 96
Carotid IMT
时间窗: 96 weeks
changes in carotid IMT is a good measure for cardiovascular disease progression
次要结局
未报告次要终点
研究者
Grace McComsey
Chief, Peds ID, Rheumatology and Global Health
University Hospitals Cleveland Medical Center