Placebo Controlled Study of Rosiglitazone in HIV Lipoatrophy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Change in Limb Fat at 48 Weeks
研究概览
简要总结
The purpose of this study is to examine the effect of rosiglitazone on limb fat and mitochondrial indices in HIV-1-infected subjects receiving stable antiretroviral therapy that does not contain stavudine (d4T) or zidovudine (AZT).
详细描述
This is a phase II, randomized, double-blind, placebo-controlled study of rosiglitazone for the treatment of HIV-associated lipoatrophy. Subjects will receive blinded study treatment for 48 weeks. This study will examine the effect of rosiglitazone on limb fat and mitochondrial indices in HIV-1-infected subjects receiving stable antiretroviral therapy that does not contain d4T or AZT. The study also will assess the safety and tolerability of rosiglitazone in this population, and its effect on carotid IMT, prevalence of metabolic syndrome, lipid parameters and glucose metabolism.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Lipoatrophy
- •Thymidine sparing ARV for at least 24 weeks
- •Prior thymidine NRTIs for at least 12 months
排除标准
- •Heart failure
- •Liver disease
- •Hormonal therapies
研究组 & 干预措施
Rosigitazone arm
Rosiglitazone active 4 mg BID
干预措施: Rosiglitazone (Drug)
Placebo arm
Matching Placebo BID
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Limb Fat at 48 Weeks
时间窗: 48 weeks
Limb fat was measured at baseline and visit week 48 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups.
次要结局
- the Change in the Carotid IMT of the Common Carotid Artery(48 weeks)