A Randomized, Phase 3, Double Blind, Multicentre Trial, Evaluating the Effect of Pioglitazone Versus Placebo on Change in Lipoatrophy in HIV- 1 Infected Patients Treated With Stable Antiretroviral Therapy for at Least 6 Months.ANRS 113 LIPIOT Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Evolution from inclusion to week 48 of limb fat using DEXA Scan (Dual Energy X-ray Absorptiometry)
研究概览
简要总结
The aim of this randomized study is to compare the effect of pioglitazone versus placebo on change in limb fat in HIV 1-infected patients treated with antiretroviral therapy for at least 6 months and with clinical lipoatrophy.
详细描述
Lipodystrophy is one of the most frequent treatment side effect in HIV-1 infected patients. This complication can be stigmatizing in some affected patients and lead to reduced adherence to treatment, increased risk of cardiovascular complications and induce insulinoresistance. The pathophysiology of lipodystrophy remains poorly understood. Some antiretroviral drugs could be involved. Therefore, using PPAR G as a therapeutic target with the objective to reverse drug induced lipoatrophy appeared as a promising objective Thiazolidinediones are a new class of insulin sensitizing drugs for the treatment of type 2 diabetes. These PPARG agonist which mainly promote the differentiation of adipocytes, decrease circulating plasma free fatty acids. In non-HIV infected patients this class of drugs decreases intraabdominal fat accumulation and increases subcutaneous fat depot.
Different previous studies were performed with that aim, most of them using rosiglitazone.
We designed a prospective randomized, double blind placebo controlled multicentre study aiming to test the hypothesis that pioglitazone would improve lipoatrophy without deleterious effect on lipid profile in adult subjects receiving antiretroviral therapy.
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
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
- •18 years of ages and older
- •Confirmed laboratory diagnosis of HIV-1-infection
- •Karnofsky equal or over 70%
- •Patients treated with stable antiretroviral therapy for at least 6 months
- •Plasma viral load below 400 copies/ ml and CD4 count over 200/mm3 for at least 6 months
- •Patients with a clinical peripheral lipoatrophy self reported by the patient and confirmed by physical examination
排除标准
- •Cardiac failure class3 or 4 at NYHA classification
- •Acute opportunistic infection
- •Pregnancy or breast-feeding
- •Polynuclear neutrophils below 1000/mm3
- •Hemoglobin below 9 g/dl
- •Platelets below 50 000/mm3
- •Creatinine level over 2 UN
- •ASAT, ALAT over 2.5UN
- •Bilirubin, amylase, lipase level over 2 UN
- •CD4 count below 200/mm3
- •Patients treated by any antidiabetic or lipid lowering drugs, anabolic or corticosteroid hormone
结局指标
主要结局
Evolution from inclusion to week 48 of limb fat using DEXA Scan (Dual Energy X-ray Absorptiometry)
次要结局
- Changes from inclusion to week 48:
- Lipid profile and the glucidic metabolism
- SAT/TAT and VAT/TAT ratios evaluated with scanner
- X ray of L4
- Anthropometric measurements and the quality of life (WHO-QOL-HIV BREF)
- Evaluation of clinical and biological safety