NCT00135356已完成4 期
A Phase IV, Open-Label, Randomized, Multicenter Trial Assessing a Reyataz-Based Substitution Approach in the Management of Lipodystrophy Syndrome. Research Into Atazanavir in Lipodystrophy (The REAL Study)
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 219 人开始时间: 2005年7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
- 219
- 试验地点
- 1
- 主要终点
- Change From Baseline in Trunk-to-limb Fat Ratio as Measured by Dual Energy X-Ray Absortiometry (DEXA) at Week 48
研究概览
简要总结
The purpose of this clinical research study is to learn if human immunodeficiency virus (HIV)-infected subjects with abdominal fat accumulation on their highly active antiretroviral treatment (HAART) regimen have better changes in fat distribution after switching to atazanavir-ritonavir than those remaining on their current protease inhibitor boosted HAART regimen.
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
- •HIV-1 infected on HAART regimen containing 2 NRTI and boosted PI for at least 12 weeks prior to screening. Subjects may not have experienced virological failure to more than one prior PI-containing regimen. Must be able to swallow tablets
- •Viral load <400 c/mL at screening and stable for at least 6 months
- •Signs of fat redistribution and lipohypertrophy (abdominal) Waist to Hip Ratio >0.90 and Waist Circumference >88.2 cm for men and Waist Circumference >75.3 for women
排除标准
- •Pregnant or breastfeeding women
- •New HIV-related opportunistic infections
- •Active alcohol or substance use
- •Grade 4 lab toxicity
- •History of taking atazanavir (ATV)
- •Prohibited therapies, including non-nucleoside reverse transcriptase inhibitors (NNRTI)
研究组 & 干预措施
Switch arm
Active Comparator
干预措施: Atazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs) (Drug)
Control Arm
Active Comparator
干预措施: continuation of current HAART (boosted protease inhibitor [PI] combination + 2 NRTIs) (Drug)
结局指标
主要结局
Change From Baseline in Trunk-to-limb Fat Ratio as Measured by Dual Energy X-Ray Absortiometry (DEXA) at Week 48
时间窗: Baseline, Week 48
Mean changes from Baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values. (Baseline trunk-to-limb fat ratio values can be found in the Baseline Characteristics section.)
次要结局
- Percentage of Participants With Abnormal Liver Function Tests(Week 48, Week 96)
- Mean Change From Baseline in CD4 Count(Baseline, Week 48, Week 96)
- Mean Percent Change From Baseline in Visceral Adipose Tissue (VAT) Area by Computed Tomography (CT) Scans and in Trunk Fat by DEXA.(Baseline, Week 48, Week 96)
- Change From Baseline in Trunk-to-limb Fat Ratio as Measured by DEXA at Week 96(Baseline, Week 96)
- Mean Percent Changes From Baseline in Fasting Lipids(Baseline, Week 48, Week 96)
- Mean Percent Change From Baseline in Total Body Fat by DEXA and in Total Adipose Tissue (TAT) Area by CT Scans(Baseline, Week 48, Week 96)
- Mean Changes From Baseline in Fasting Glucose at Week 48 and Week 96(Baseline, Week 48, Week 96)
- Mean Percent Change From Baseline in Peripheral Adipose Tissue (Limb Fat) by DEXA and by Changes in Subcutaneous Adipose Tissue (SAT) Area by CT Scans(Baseline, Week 48, Week 96)
- Mean Changes From Baseline in Fasting Insulin at Week 48 and Week 96(Baseline, Week 48, Week 96)
- Mean Changes From Baseline in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)(Baseline, Week 48, Week 96)
- Mean Changes From Baseline in Body Weight at Week 48 and Week 96(Baseline, Week 48, Week 96)
- Mean Changes From Baseline in Waist Circumference at Week 48 and Week 96(Baseline, Week 48, Week 96)
- Mean Changes From Baseline in Body Mass Index at Week 48 and Week 96(Baseline, Week 48, Week 96)
- Mean Changes From Baseline in Waist-to-Hip Ratio at Week 48 and Week 96(Baseline, Week 48, Week 96)
- Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation(Through Week 96 of study therapy)
- Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation(Through Week 96)
- Kaplan-Meier Cumulative Proportion of Participants Without Virologic Rebound (HIV RNA ≥400 c/mL) at Timepoints up to Week 96 in Treated Participants With HIV RNA <400 c/mL at Baseline(Weeks 8-12, Weeks 20-24, Weeks 32-36, Weeks 44-48, Weeks 56-60, Weeks 68-72, Weeks 80-84, Weeks 92-96)
研究者
研究点 (1)
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