Metabolic Effects of Switching Kaletra to Boosted Reyataz
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Glucose Trafficking
研究概览
简要总结
To study the effects of switching from Kaletra to Boosted Reyataz on glucose, lipids and fat in HIV-infected patients.
详细描述
The primary objective of this study is to determine tissue specific glucose trafficking in patients before and after switching from a regimen containing Lopinavir/ritonavir (LPV/r) to one containing atazanavir/ritonavir (ATV/r). Secondary outcome measures of interest will include insulin sensitivity determined by clamp testing, and lipid metabolism and hepatic glucose production assessed using stable isotope techniques. We hypothesize that switching protease inhibitor (PI) to ATV/r from LPV/r will result in direct increases in glucose uptake in muscle and visceral adipose tissue in association with improvements in overall whole body insulin sensitivity compared to remaining on LPV/r. We will complete a prospective randomized trial of Human Immunodeficiency Virus (HIV) infected patients who have been on a stable antiretroviral (ARV) regimen containing LPV/r for at least 6 months and who will be randomized to either switch to a regimen containing ATV/r or remain on LPV/r for 6 months. Each subject will complete Positron Emission Tomography (PET) 18-fluorodeoxyglucose (FDG) imaging during a hyperinsulinemic clamp study at baseline and 6 months after randomization.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously diagnosed HIV infection
- •Age between 18-65 years
- •Stable antiviral regimen containing at least 2 nucleoside reverse transcriptase inhibitors (NRTI's) and LPV/r for ³ 6 mos
- •CD4 count > 400 cell/mm3
- •Metabolic complication as indicated by one or more of hyperinsulinemia (fasting insulin >= 15 mIU/ml), hypercholesteremia (fasting total cholesterol >= 200 mg/dL), hypertriglyceridemia (fasting triglycerides >= 150 mg/dL), or treatment with a lipid lowering medication.
排除标准
- •Hemoglobin < 11.0 g/dL
- •History of Diabetes Mellitus
- •Currently on medication for Diabetes
- •Therapy with glucocorticoid, growth hormone or other anabolic agents currently or within the past 3 months
- •Current substance abuse, including alcohol, cocaine and/or heroin
- •Any contraindication to ATV/r or known allergy to ATV
- •Concurrent therapy with: Bepridil; cisapride; ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine); indinavir; irinotecan; lovastatin; midazolam; pimozide; proton pump inhibitors (esomeprazole, lansoprazole, omeprazole); rifampin; simvastatin; St John's wort; or triazolam
- •New or serious opportunistic infection in the past 3 months
研究组 & 干预措施
1
Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
干预措施: atazanavir/ritonavir (Drug)
2
Kaletra (pre-study dose)
干预措施: lopinavir/ritonavir (Drug)
结局指标
主要结局
Glucose Trafficking
时间窗: 6 months
6 month mean and standard deviation for glucose uptake into anterior thigh muscle as measured by FDG/PET scanning during euglycemic hyperinsulinemic clamp. During the hyperinsulinemic conditions of the clamp, glucose and 18-FDG \[labeled glucose\] are taken up by muscle. The quantity of 18-FDG taken up is measured by the PET scan. Although there are no well-accepted norms for this measurement, a higher value indicates that more glucose is being taken up by (or "trafficked to") muscle. Increased uptake of glucose indicates increased muscle insulin sensitivity.
次要结局
- Insulin Sensitivity(6 months)
- Fasting Glucose(6 months)
- Liver Enzymes -- Aspartate Aminotransferase (AST)(6 months)
- Liver Enzymes -- Alanine Aminotransferase (ALT)(6 months)
- Total Bilirubin(6 months)
- Lipid Metabolism - Serum Triglyceride(6 months)
- Body Composition - Visceral Adipose Tissue(6 months)
- Immune Parameters -- CD4 Count(6 months)