Effect of Rosiglitazone Maleate (Avandia®) on Carotid Intima Media Thickness, Brachial Artery Reactivity, Glucose Metabolism, Blood Lipid Concentrations, Body Fat Distribution, and Biochemical Markers of Cardiovascular Risk in Patients With the HIV Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Carotid intima media thickness (IMT)
研究概览
简要总结
This trial will study the effect of rosiglitazone on the progression of atherosclerosis (hardening of blood vessels) through improvements of the sugar and fat metabolism (body buildup, breakdown and excretion of sugar and fat).
Participants will be randomly assigned to one of two groups: the first group will receive 8 mg of the study drug and the second group will be given a placebo, though neither group will know which formulation they are receiving. The study will follow both groups for one year, during which it will measure changes in blood vessel composition and activity, sugar metabolism, concentration of blood fat, and body fat distribution. This single-site study aims to enroll 50 participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-positive
- •Between 30 and 70 years of age
- •Elevated blood levels of fat
- •On two or more anti-HIV drugs for at least12 months in a row and unlikely to change anti-HIV therapy during the study
- •On stable regimen for at least 6 months for women taking oral contraceptive agents or hormone replacement
- •On a stable regimen for at least 6 months for men on testosterone replacement
- •If taking nevirapine, on therapy for at least 3 months with stable liver function tests
排除标准
- •Pregnancy and breastfeeding
- •Poorly controlled diabetes
- •Uncontrolled hypertension or clinical evidence of heart failure
- •Any serious medical conditions, including an active AIDS-defining condition, pancreatitis, or hepatitis within 6 months prior to the study
- •Laboratory abnormalities (see investigator)
- •On lipid lowering agents, insulin, anabolic steroids (except for testosterone at replacement doses), oral corticosteroids at greater than replacement doses, or growth hormones
- •History of liver reaction or severe edema associated with current thiazolidinedione
- •History of hypersensitivity to thiazolidinedione
研究组 & 干预措施
1
The first group will receive 8 mg of the study drug (rosiglitazone).
干预措施: Rosiglitazone maleate (Drug)
2
The second group will be given a placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Carotid intima media thickness (IMT)
时间窗: 1 year
次要结局
- Changes in glucose metabolism(1 year)
- Changes in concentrations of blood lipids(1 year)
- Changes in C-reactive protein(1 year)
- Changes in pre-inflammatory cytokines (MCP-1, IL-6) and adipocytokines (RBP-4, adiponectin)(1 year)