NCT00978237已完成4 期
CT to Assess the Effect on the Subcutaneous Fat of Change of EFV for LPV/r in HIV-infected Patients Who Developed Lipoatrophy and Remains Despite Treatment With Efavirenz and Fixed-dose Combination of no Thymidine Nucleoside Analogues.
Juan A. Arnaiz7 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2009年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 7
- 主要终点
- Absolute change in limb fat mass measured by DEXA.
研究概览
简要总结
Eligible HIV-infected patients with clinically evident lipoatrophy despite treatment with efavirenz and fixed-dose combination of thymidine nucleoside analogues will be informed and asked to enroll in the study; will be randomized (1:1) into two branches, A: EFV + Fixed combinations of analogue tenofovir + emtricitabine.B (experimental): LPV/r + combination of correspondent analogues. The main variable is the evaluation of the absolute change in limb fat mass at 24 months from baseline in both groups.
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
- 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
- •Patients HIV positive > 18 years.
- •Patients in treatment with Sustiva(r)+Truvada(r); or Sustiva (r)+Kivexa(r).
- •HIV-ARN < 50 copies/mL in the las six months.
- •Clinically evident lipoatrophy (moderate or severe).
- •Negative pregnancy test.
- •Signed informed consent.
排除标准
- •Evidence of failure or mutation to therapy with protease inhibitors.
- •Patients that can not be treated with LPV/r.
- •Mild lipoatrophy.
- •History of alcoholism or drug addiction that discourages participation in the study.
- •Pregnancy or breastfeeding.
- •Documented current or 4 weeks prior opportunistic infection.
- •Creatinin clearance < 60mL/min.
- •Concomitant use of nephrotoxic drugs or immunosuppressants.
- •Actual treatment with systemic corticosteroids, IL-2 or chemotherapy.
- •Patients under treatment with other drugs in investigation.
- •Acute hepatitis.
- •Any other disease that discourages participation.
研究组 & 干预措施
EFV and Fixed combinations of analogues
Active Comparator
EFV + Fixed combinations of analogue tenofovir + emtricitabine, or abacavir + lamivudine
干预措施: EFV (Drug)
LPV/r and combination of analogues.
Experimental
干预措施: LPV/r (Drug)
结局指标
主要结局
Absolute change in limb fat mass measured by DEXA.
时间窗: 24 months.
次要结局
未报告次要终点
研究者
Juan A. Arnaiz
MD, PhD
Hospital Clinic of Barcelona
研究点 (7)
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